Do you have questions about medical devices you use at home? There are many such devices, from ventilators to blood pressure monitors.

Learn more during a 30-minute webinar hosted by the Food and Drug Administration’s Center for Devices and Radiological Health. An FDA expert will discuss how FDA plans to address the increased use of medical devices in the home and will talk briefly about the new technology that is focusing on self-care and self-monitoring.

The public will have an opportunity to ask questions following the presentation.

When: Thursday, July 28, 2011, at 2:00 p.m. (ET)

Length: 30 minutes

Where: To join the webinar, see the instructions here

Host: FDA's Center for Devices and Radiological Health

Featured speaker: Mary Brady, senior policy analyst in the Office of the Center Director, Center for Devices and Radiological Health

This webinar is part of a series of online sessions hosted by different FDA centers and offices. The series is part of FDA Basics, a Web-based resource aimed at helping the public better understand what the agency does.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

 

Do you know how vaccines are developed and approved? Or how the Food and Drug Administration (FDA) ensures that vaccines are safe and effective in preventing disease?

Learn about the vital role that FDA plays in protecting the health of our nation’s children through regulation of vaccines in this 30-minute webinar. An FDA expert will discuss the importance of vaccines to a child’s health, the development process for vaccines, how FDA makes sure vaccines that are granted licensure (approval) are safe and effective, and how the agency oversees their continued safety and effectiveness.

An opportunity to ask questions will follow the presentation.

When:  Thursday, Aug. 18, 2:00 p.m. ET

Length: 30 minutes

Where:  To join the webinar, see the instructions here. Webinar slides will be posted here also.

Host: Office of Vaccines Research and Review within FDA’s Center for Biologics Evaluation and Research

Featured speaker: Norman Baylor, Ph.D., director of the Office of Vaccines Research and Review within FDA’s Center for Biologics Evaluation and Research

This webinar is part of a series of online sessions hosted by different FDA centers and offices. The series is part of FDA Basics, a Web-based resource aimed at helping the public better understand what the agency does.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

Photo courtesy of J. Zirato, University of Arizona BioCommunications

 

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“Once stung, twice shy” are words to live by in the Southwestern United States, where about 11,000 people a year are stung by scorpions in Arizona alone.

Though rarely life threatening, scorpion stings can be extremely painful, causing numbness and burning at the wound site. And there’s been little a victim could do to ease the pain.

Until now.

The Food and Drug Administration has just approved the first treatment specifically for the sting of the Centruroides scorpion, the most common type in the United States.

The new biologic treatment—called Anascorp—was given a priority review because adequate treatment did not exist in the United States, says Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

“This product provides a new treatment for children and adults and is designed specifically for scorpion stings,” Midthun says. “Scorpion stings can be life-threatening, especially in infants and children.”

Severe stings can cause loss of muscle control and difficulty breathing, requiring heavy sedation and intensive care in a hospital. Most often, it’s small children who experience severe reactions, but adults can be affected, too, says Keith Boesen, managing director of the Arizona Poison and Drug Information Center (APDIC).

Boesen says Arizona’s two poison centers document about 11,000 scorpion stings each year; 17,000 stings were reported to U.S. poison centers nationwide in 2009.

“We at the APDIC and University of Arizona College of Pharmacy are very excited (about Anascorp’s approval). I am proud of the expertise of the pharmacists and physicians working at the APDIC who helped make this research possible,” he says.

Anascorp was developed in Mexico and has been used there for many years, according to University of Arizona researchers who led the U.S. study of the drug. It’s made from the plasma of horses immunized with scorpion venom and vaccinated against viruses that could infect humans. Researchers began studying the drug in Arizona hospitals in 2004 and found it to be highly effective against the sting of the bark scorpion (also called the Arizona bark scorpion)—the most poisonous scorpion in the U.S.

Without Anascorp, children experiencing the most severe symptoms usually had to stay in intensive care in the hospital for several days; but when Anascorp was administered, researchers found patients’ symptoms disappeared after a few hours in the emergency room—eliminating the need for a hospital stay.

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The bark scorpion is found primarily in Arizona, but it also lives in other areas of the Southwest and northern Mexico, according to the Arizona-Sonora Desert Museum in Tucson, Ariz.

Scorpions are attracted to dark, moist spaces. They like to hide under rocks, wood, loose tree bark or anything else lying on the ground during the day, and they become active at night. Landscapers and others who work outside are at risk of being stung, as are people participating in outdoor activities.

Because they’re small and adept at climbing, scorpions may hitch a ride into homes in a sack of groceries or piece of clothing. Once indoors, they may get trapped in the sink or bathtub, look for a place to hide in an attic or crawl space, or scale the walls or ceiling, according to the desert museum website. Victims often report being stung while sleeping.

In June, a 6-month-old Arizona girl was airlifted from the small town of Oracle, Ariz., to University Medical Center in Tucson after a scorpion stung her as she slept, KSAZ-TV in Phoenix reported. Stephanie Moors, the child’s mother, was attending a yoga retreat and had just put her daughter down for a nap when she saw a scorpion’s tail wriggling under the child’s head. The girl was crying, vomiting, and, eventually, convulsing on the way to the hospital 36 miles away, but she made a full recovery after spending five days in the hospital.

The desert museum says you can check your home for scorpions by illuminating rooms with a black light flashlight or portable unit or a black light bulb in a lamp. Scorpion will glow a light blue-green color under the ultraviolet rays of a black light.

Jude McNally, the medical science liaison at Rare Disease Therapeutics, says the Tennessee company will market the new drug to any health care facility that accepts emergency patients in areas were the bark scorpion is found. That’s Arizona, as well as areas of Clark County, Nev., and parts of New Mexico where the bark scorpion has established colonies, he says.

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The Arizona Poison and Drug Information Center says most stings to healthy, young adults can be managed at home with basic first aid and follow-up. Victims should

clean the site with soap and waterapply a cool compresselevate the affected limb to the same level as your hearttake aspirin or acetaminophen as needed for minor discomfort

If a child is stung or the victim experiences severe symptoms, go to a medical facility immediately. If the child is under 5 years old or if an older patient is experiencing more than minor discomfort, call the poison center at 1-800-222-1222.

Made by Instituto Bioclon in Mexico City, Anascorp may cause early or delayed allergic reactions in people sensitive to horse proteins. The manufacturing process includes steps to decrease the chance of allergic reactions and to reduce the risk of transmission of viruses that may be present in the horse plasma.

FDA determined Anascorp was effective based on the results of an initial placebo-controlled, double-blind study of 15 children with neurological signs of scorpion stings. During placebo-controlled, double-blind studies, some patients get the medicine being tested, and others get a placebo—and even the researcher doesn’t know who gets which treatment. In the Anascorp study, symptoms disappeared within four hours in the eight subjects who received the antidote, but only one of the seven who received a placebo recovered so quickly.

In total, safety and efficacy data were collected from 1,534 patients in the studies led by the University of Arizona. The most common side effects of Anascorp were vomiting, fever, rash, nausea, itchiness, headache, runny nose, and muscle pain.

Experts say desert dwellers should know the symptoms of a scorpion sting and get treatment if severe symptoms develop. Severe symptoms include shortness of breath, fluid in the lungs, breathing problems, excess saliva, blurred vision, slurred speech, trouble swallowing, abnormal eye movements, muscle twitching, thrashing of the arms and legs, trouble walking, and other, uncoordinated muscle movements.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

To find out if an over-the-counter medicine contains acetaminophen, look for “acetaminophen” on the Drug Facts label under the section called “Active Ingredient.” Get hi-res version of this photo on Flickr.

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You’re in the drug store, looking for a fever-reducing medicine for your children. They range in age from 6 months to 7 years, and you want to buy one product you can use for all of them. So you buy liquid acetaminophen in concentrated drops for infants, figuring you can use the dropper for the baby and a teaspoon for the oldest.

This could be a dangerous mistake.

This use of concentrated drops in much larger amounts—as would be given with a teaspoon—can cause fatal overdoses, says Sandra Kweder, M.D., deputy director of the Food and Drug Administration’s Office of New Drugs.

You can’t just give an older child more of an infant’s medicine, adds Kweder. “Improper dosing is one of the biggest problems in giving acetaminophen to children.”

Confusion about dosing is partly caused by the availability of different formulas, strengths, and dosage instructions for different ages of children.

Sold as a single active ingredient under such brand names as Tylenol, acetaminophen is commonly used to reduce fever and relieve pain. It is also used in combination with other ingredients in products to relieve multiple symptoms, such as cough and cold medicines. Acetaminophen can be found in more than 600 over-the-counter (OTC, or non-prescription) and prescription medicines.

Improper dosing is one of the biggest problems in giving acetaminophen to children.

Acetaminophen is generally safe and effective if you follow the directions on the package, but if you give a child even a little more than directed or give more than one medicine that contains acetaminophen, it can cause nausea and vomiting, says Kweder.

In some cases—in both adults and children—it can cause liver failure and death. In fact, acetaminophen poisoning is a leading cause of liver failure in the U.S.

An FDA Advisory Panel of outside experts met May 17-18, 2011, to discuss how to minimize medication errors and make children’s OTC medicines that contain acetaminophen safer to use.

The panel recommended:

That liquid, chewable, and tablet forms be made in just one strength. Currently, there are seven strengths available for these forms combined.That dosing instructions to reduce fever be developed for children as young as 6 months. Current instructions apply to children ages 2 to 12 years and for those under 2, only state “consult a doctor.”That dosing instructions be based on weight, not just age.Setting standards for dosing devices, such as spoons and cups, for children’s medicines. Currently, some use milliliters (mL) while others use cubic centimeters (cc) or teaspoons (tsp).

“FDA is considering these recommendations,” says Kweder, and for those that the agency adopts, “we will work with manufacturers to try to get them in place on a voluntary basis.” The process of getting a regulation finalized could take several years, she adds, so having the drug industry act voluntarily would help make acetaminophen safer sooner.

Drug makers have already agreed to phase out the concentrated infant drops to reduce confusion for parents who try to use them for older children. On May 4, 2011, the Consumer Healthcare Products Association, a trade group representing the makers of OTC medicines, announced plans to convert liquid acetaminophen products for children to just one strength (160 mg/5 mL). In addition, the industry is voluntarily standardizing the unit of measurement “mL” on dosing devices for these products.

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Under a 2009 FDA regulation, manufacturers must place the word “acetaminophen” on the front of the package of all OTC products that contain the ingredient and on the “Drug Facts” label on the container and packaging.

However, prescription medicines don’t have Drug Facts labels. Instead, the pharmacy places a computer-printed label based on the doctor’s prescription on the container before giving it to the consumer. Pharmacies often use the acronym “APAP” (N-acetyl-p-aminophenol) or a shortened version of acetaminophen to represent the ingredient. If parents don’t know these abbreviations, they might not recognize that a prescription medicine contains acetaminophen and could accidentally overdose a child by giving a prescription and an OTC acetaminophen medicine at the same time.

FDA’s Safe Use Initiative, which fosters collaborations within the health care community to help prevent harm from medications, has been working to bring about the complete spelling of acetaminophen on prescription containers.

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Never give your child more than one medicine containing acetaminophen at a time. To find out if an OTC medicine contains acetaminophen, look for “acetaminophen” on the Drug Facts label under the section called “Active Ingredient.” For prescription pain relievers, ask the pharmacist if the medicine contains acetaminophen.Choose the right OTC medicine based on your child’s weight and age. The “Directions” section of the Drug Facts label tells you if the medicine is right for your child and how much to give. If a dose for your child’s weight or age is not listed on the label or you can’t tell how much to give, ask your pharmacist or doctor what to do.Never give more of an acetaminophen-containing medicine than directed. If the medicine doesn’t help your child feel better, talk to your doctor, nurse, or pharmacist.If the medicine is a liquid, use the measuring tool that comes with the medicine—not a kitchen spoon.Keep a daily record of the medicines you give to your child. Share this information with anyone who is helping care for your child.If your child swallows too much acetaminophen, get medical help right away, even if your child doesn’t feel sick. For immediate help, call the 24-hour Poison Control Center at 800-222-1222, or call 911.

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The Food and Drug Administration (FDA) has released its “Strategic Plan for Regulatory Science,” a sweeping initiative to modernize the tools and methods that the agency uses to evaluate whether the products it regulates are effective and safe for consumers.

Regulatory science is the foundation of decision-making at FDA. Researchers across FDA gather data, do tests and think of new, better and faster ways to scientifically establish that regulated products enhance—without harming—the lives of the American public.

Products regulated by FDA include biologics (such as blood products and vaccines), human drugs, medical devices, foods, cosmetics, tobacco products, and animal feed and drugs. The broad scope of FDA’s plan covers the personal health of the consumer, the strength of the economy and the security of the nation.

“As new discoveries yield increasingly complex products, FDA’s experts need to be equipped to make science-based decisions resulting in sound regulatory policy,” says Commissioner of Food and Drugs Margaret A. Hamburg, M.D.

“It’s really about using science to protect and promote public health,” says Jan N. Johannessen at FDA’s Center for Drug Evaluation and Research. “Advancements in science create tremendous opportunities to improve how products are developed and evaluated.”

“We want to ensure that these advances benefit patients,” says Johannessen.  “Our research is vital to ensuring the safety and effectiveness of the products we regulate,” adds Carolyn A. Wilson, PhD, at FDA’s Center for Biologics Evaluation and Research.

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The framework of the regulatory science initiative was originally released in October 2010. The new plan fills in the details and focuses on eight key areas:

Modernizing toxicology—the study of chemical, biological or physical agents that can be harmful—and improving the ability of tests, models and measurements to predict product safety issues. This includes, where feasible, the development of new methods that could reduce or replace animal testing.Crafting new tools and approaches for the development of personalized medicine—getting the right medicine to the right person at the right time.Supporting new and improved manufacturing methods by researching how new technologies affect product safety, effectiveness and quality.Ensuring that FDA is ready to evaluate innovative and emerging technologies with the necessary expertise and infrastructure.Expanding and improving FDA’s information technology infrastructure and the application of those resources to support sophisticated analyses of data.Implementing the prevention-focused food-safety system mandated by the Food Safety Modernization Act passed by Congress and signed into law by President Obama in January.Speeding the development of safe and effective medical countermeasures to protect against threats to U.S. health and security, such as chemical, biological, or nuclear threats or naturally occurring infectious disease outbreaks. Such countermeasures include drugs, vaccines, diagnostic tests and personal protective equipment.Developing a communications strategy that will help FDA adapt to rapidly evolving technologies that are changing how people receive and share information.

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“As new discoveries yield increasingly complex products, FDA’s experts need to be equipped to make science-based decisions resulting in sound regulatory policy.”

Why should you care about regulatory science?

What it boils down to, says FDA’s Chief Scientist Jesse Goodman, is that people want new drugs, healthy food and other products that work. They want them to be developed and approved quickly, but they also want these things to be safe.

And that’s where regulatory science comes in. Here are a few examples of how this science has worked so far:

A clinical trial model was developed to help scientists quickly test the most promising drugs in development to treat women with rapidly growing breast cancers. The drugs are targeted to the biology of each woman’s tumor using specific genetic or biological markers.By studying data from hundreds of clinical trials, FDA found that antidepressants can increase the risk of suicide in people under 25. This resulted in FDA placing warnings on the labeling and medication guides for these drugs. After the Deepwater Horizon disaster released in excess of 92 million gallons of oil into the Gulf of Mexico in 2010, FDA developed a more rapid, highly sensitive chemical testing method to ensure that seafood from the Gulf is safe for consumption.

“The headlines are replete with examples of the critically important scientific role the agency plays in addressing crises, such as contaminated heparin, melamine in pet food, outbreaks of foodborne illness, and questions about vaccine safety, seafood safety, or readiness for pandemic influenza,” the strategic plan states.

“A strong FDA science infrastructure provides the essential foundation for ensuring scientific excellence and integrity in all of our regulatory and public health decisions and activities.”

Or, as Goodman says succinctly, “Strong and up-to-date science in these areas will help us do our jobs better—to help people be as healthy, safe and secure as possible.”

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

 

This campus in Jefferson, Arkansas, houses all National Center for Toxicological Research operations, as well as the Arkansas Regional Laboratories, another FDA facility. For more photos of NCTR, visit Flickr.

NCTR researchers Dan Buzatu (right) and Jon Wilkes invented the Rapid-B system to detect live pathogens in foods. For more photos of NCTR, visit Flickr.

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A federal research center born in the Cold War era is celebrating its 40th birthday and its reputation as one of the world’s premier science centers.

The National Center for Toxicological Research (NCTR) is marking its anniversary by formalizing a partnership with the state of Arkansas to create a virtual Center for Regulatory Science. The center’s goals will include modernizing this field of research to bring safer products to the market faster, and increasing the understanding of the potential toxicity of nanotechnology-based products.

But all of NCTR’s work, which spans many fields of science and includes a smorgasbord of new technologies, is really about regulatory science, explains Center Director William Slikker, Jr., Ph.D. The center’s focus is on both the development of new approaches to evaluating the safety of products regulated by the Food and Drug Administration (FDA) and the creation of data sets that substantiate and guide regulatory decisions, he says.

NCTR researchers often study a product before it’s even gone through clinical trials. At other times, they study products that have been around a long time but have unforeseen qualities. No matter what the product or health issue, Slikker says, “We develop data to fill the knowledge gap.”

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In 1971, President Richard Nixon announced the establishment of the National Center for Toxicological Research on 500 acres in Jefferson, Arkansas. The site was once part of the U.S. Army’s Pine Bluff Arsenal but when President Nixon ordered the creation of this new center, it got a new home—the FDA.

NCTR’s initial mission was to study the effects of toxic chemicals on people and their environment. In the 40 years that have followed, NCTR has established itself as an internationally renowned research center, one that studies toxicity in chemicals, drugs and food, in addition to identifying the biomarkers for terrorism. The center studies human susceptibility to toxicants and the risk of disease. Toxicants are chemical, biological or physical agents that can be harmful to people, plants and animals.

The multidisciplinary teams of researchers—partnering with colleagues in other government agencies, industry and academia—also tackle a spectrum of personal and public health issues, including those affecting women and minorities in particular, as well as foodborne pathogens, and personalized nutrition and medicine.

The center has more than 500 scientists and other personnel in 30 buildings, in addition to the students, postdoctoral fellows, visiting scientists and FDA staff who come to NCTR to learn new technologies. “We’ve trained hundreds of individuals over the years,” says Slikker.

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“An important part of modernizing the FDA ... to better protect and promote the public health.”

To celebrate its birthday, FDA and NCTR are taking that research another big step further with the signing of an agreement with the State of Arkansas to create the Center of Excellence for Regulatory Science.

Slikker explained that the agreement is, in a sense,  a formalization of NCTR’s long association with researchers at the University of Arkansas for Medical Sciences and other state universities and institutions. There will be a particular focus on the study of the safety and efficacy of nanotechnology, he says.

The center is virtual in the sense that its work will be conducted in both state and federal facilities. There will be an expanded sharing of resources, facilities and education initiatives that target both students and members of the public.

FDA Commissioner Margaret A. Hamburg, M.D.,  calls the agreement with Arkansas “an important part of modernizing the FDA through the leveraging of intellectual, human and financial resources to better protect and promote the public health.”

Beyond this, NCTR has developed technologies that could one day transform healthcare. They include:

RAPID-B, a portable system that can instantly detect live pathogens (infectious agents that can cause disease)—such as E. coli 0157, Salmonella and Listeria. This can be used for on-site surveillance of food-producing facilities and for the detection of potential contamination of biological cells and tissues.Bioinformatics, the use of computers and math to answer questions about biology. In general, an example of this technology would be software tools that search for certain properties within DNA sequences. At  NCTR, teams of scientists from academia, industry and the government have been working together to create the standards, approaches and bioinformatic tools that will enable researchers to mine rich fields of biological data.Improvements in scanning devices—noninvasive magnetic resonance spectroscopy and MicroPET—to provide informative, translatable and much lower-risk diagnostics.Nanotechnology in cancer therapy that could make it possible to target difficult-to-treat or inoperable cancers.

And there’s promising research underway in the area of personalized medicine, says Slikker. “How do you deal with large data sets and try to develop safety information that’s important to the individual—that’s personalized? This is really exciting."

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

Click the button below to submit a comment on the proposed guidelines:

Consumers with celiac disease must avoid gluten—proteins found in baked goods made with wheat and some other grains. For people not sensitive to gluten, there is no health benefit to a gluten-free diet.

Some foods are naturally free of gluten. Here are some examples:

milk not flavored with ingredients that contain gluten, such as malt100 percent fruit or vegetable juicesfresh fruits and vegetablesbuttereggslentilspeanutsseeds, such as flaxtree nuts, such as almondsnon-gluten-containing grains, such as cornfresh fish, such as codfresh shellfish, such as clamshoneywater, including bottled, distilled, and spring

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Whether as muffins, rolls, or loaves, wheat bread is found in most households. But few consumers may appreciate the substance that helps the dough rise, keeps the bread from falling apart, makes it chewy, and adds to its flavor.

That substance is gluten. Breads, cakes, cereals, pastas, and many other foods are made with wheat or added wheat gluten to improve their baking quality and texture.

Technically, gluten represents specific proteins that occur naturally in wheat. However, the term “gluten” is commonly used to refer to certain proteins that occur naturally not only in wheat, but also in rye, barley, and crossbreeds of these grains and that can harm people who have celiac disease. The only treatment for this disorder is a life-long gluten-free diet.

Eating gluten doesn’t bother most consumers, but some people with celiac disease have health-threatening reactions, says Stefano Luccioli, M.D., a Food and Drug Administration (FDA) allergist and immunologist. They need to know whether a food contains gluten.

FDA has been working to define “gluten-free” to:

eliminate uncertainty about how food producers may label their products.assure consumers who must avoid gluten that foods labeled “gluten-free” meet a clear standard established and enforced by FDA.

FDA’s actions on Aug. 2 bring the agency one step closer to a standard definition of “gluten-free.” On this date:

FDA reopens the public comment period on its proposed gluten-free labeling rule published on Jan. 23, 2007.FDA makes available, and seeks comments on, a report on the health effects of gluten in people with celiac disease. The report includes a safety assessment on levels of gluten sensitivity in people with the disease.

According to the National Institutes of Health, celiac disease affects as many as 1 percent of the U.S. population.

The disease occurs when the body’s natural defense system reacts to gluten by attacking the lining of the small intestine. Without a healthy intestinal lining, the body cannot absorb the nutrients it needs. Delayed growth and nutrient deficiencies can result and may lead to conditions such as anemia and osteoporosis. Other serious health problems may include diabetes, autoimmune diseases, and intestinal cancers.

“Some people don’t get immediate symptoms, but when they do, they are typically gastrointestinal-related, such as abdominal pain, bloating, and diarrhea,” says Luccioli. “In infants, there may be a lot of vomiting, and they don’t grow and thrive.” And some people do not have any symptoms at all, adds Luccioli, but still may have intestinal damage and risk for long-term complications. It is important for individuals with celiac disease, who may vary in their sensitivity to gluten, to discuss their dietary needs with their health care professional.

Grocery shopping is challenging for people with this disease, says Andrea Levario, J.D., executive director of the American Celiac Disease Alliance. “When they find a product labeled ‘gluten-free,’ they don’t necessarily know what that means because today there is no federal standard for the use of this term.”

Having a federal definition of “gluten-free” is critically important, says Levario. “If we have one national standard, the individual will know that all products labeled ‘gluten-free’ will have no more than a minimal amount of gluten.”

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“Eating gluten-free is not meant to be a diet craze,” says Rhonda Kane, a registered dietitian and consumer safety officer at FDA. “It’s a medical necessity for those who have celiac disease.” 

“There are no nutritional advantages for a person not sensitive to gluten to be on a gluten-free diet,” she adds. “Those who are not sensitive to gluten have more flexibility and can choose from a greater variety of foods to achieve a balanced diet.”

Gluten-free is not synonymous with low fat, low sugar, or low sodium. For people who must be on a gluten-free diet, Kane says it's important to check the ingredients list and Nutrition Facts information on food labels to find the most nutritious options.

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In 2007, FDA proposed to allow manufacturers to label a food “gluten-free” if the food does not contain any of the following:

an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grainsan ingredient derived from these grains and that has not been processed to remove glutenan ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten20 ppm or more gluten

In the notice reopening the comment period, FDA states that it continues to believe the proposed definition of “gluten-free” is the correct one.

FDA’s notice also describes current analytical methods that can reliably and consistently detect gluten at levels of 20 ppm or more in a variety of foods. 

The agency is interested in hearing from the public and industry. The public comment period on the proposed rule will officially open after noon on Aug. 3, 2011, and will remain open for 60 days. To submit comments electronically, go to www.regulations.gov and

choose “Submit a Comment” from the top task barenter the docket number FDA-2005-N-0404 in the “Keyword” spaceselect “Search”

After FDA reviews and considers the comments, the agency will issue a final rule that defines “gluten-free” for labeling food products, including dietary supplements.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Aug. 2, 2011

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When flu season arrives this fall, a liquid form of Tamiflu—the most widely used anti-viral flu medication—will be available in a new, lower concentration to reduce the possibility of medication errors.

The change applies to the oral suspension form of Tamiflu and not the capsule. Oral suspension is a powder form of the prescription medication that a pharmacist mixes with water to make a liquid treatment easier to take by children or adults who are unable to swallow a Tamiflu capsule.

The Tamiflu packaging of its oral suspension product says “new strength” because the concentration of medicine in the liquid has been changed from 12 mg/mL (milligrams per milliliter) to 6 mg/mL. This change in concentration means that the amount of medicine that must be taken has also changed.  If taken as directed, the medicine is still as effective as it was before.

The Food and Drug Administration worked with Genentech Inc, manufacturer of Tamiflu, to create the new 6 mg/mL medication to reduce the possibility of errors in getting the correct dose. It will replace the 12 mg/mL concentration, which will no longer be manufactured but will be available until expiration.

Tamiflu is FDA-approved to treat adults and children older than 1 year who have had influenza symptoms for two days or less. Tamiflu stops the virus from spreading in the body and can help shorten the duration of such symptoms as a stuffy or runny nose, sore throat, cough and muscle aches.

Linda Lewis, medical team leader in FDA’s Division of Antiviral Products, explains that there have been no reported cases of serious side effects related to medication errors involving oral suspension Tamiflu. But there were many reports of confusion about prescribing and taking the right dose during the influenza pandemic in 2009, Lewis says.

That’s because when mixed as directed, the 12 mg/mL concentration gets frothy and bubbly and it can be difficult to get the right amount. “We were concerned that the measurement of the dose was not very reliable,” Lewis says. She adds that the mixture is not frothy when the concentration is lower.

Containers of the low-concentration medication will come with new dosing instructions based on body weight.

In addition, the dosing device has been changed to a 10-milliliter oral syringe, which will make it easier to accurately measure the correct dose. The dosing device originally packaged with the 12 mg/mL suspension was marked in 30 and 45 mg, which caused confusion in measuring the liquid medication.

Because there are no quality issues with the 12 mg/mL concentration Tamiflu, it will remain on the market until supplies run out and can be used until its expiration date.

With both dose concentrations being available during the flu season this fall, Kendall Marcus, safety deputy in FDA’s Division of Antiviral Products, cautions that pharmacists and physicians will have to be particularly careful in prescribing and dispensing the medication.

After the next flu season, only the 6 mg/mL concentration will be available.

Marcus says consumers need to know the following:

You could receive either the 6 mg/mL or the 12 mg/mL version at your local pharmacy during the next flu season. If you have any questions about how to use the product safely, speak to your pharmacist or other health care provider.If you have taken oral suspension Tamiflu in the past, the container and label will look different.The new oral dosing device is different and the volume (mL) of your dose may differ from past prescriptions.If you have any problems with the medication, report them to your health care provider and to FDA’s MedWatch program.

Marcus notes that pediatric strength Tamiflu capsules (30 mg and 45 mg) have not changed and are still available for children who can swallow capsules. Another option for parents is to open the capsule and mix its contents with a flavored food, like chocolate syrup.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Medicines are powerful. They can cure disease, relieve symptoms, and help you stay healthy. But they can also do a lot of damage if taken incorrectly, when not needed, or when prescribed inappropriately.

The Food and Drug Administration (FDA) believes that many medication-related risks can be prevented if everyone committed to the safe use of medicines works together. Acting on that belief, the agency launched the Safe Use Initiative in November 2009 to foster collaborations within the health care community that will help prevent medication errors, misuse, and abuse.

Studies estimate that up to 50 percent of harm from medication use could be prevented. According to the Institute of Medicine, this would translate into about 1.5 million preventable incidents each year.

The goal of the Safe Use Initiative is to

identify specific, preventable harm related to medication usedevelop methods (interventions or strategies) to reduce harmidentify ways to measure the success of these interventions

Tens of millions of people in the U.S. take prescription or over-the-counter (non-prescription) medicines each year, says Karen Weiss, M.D., director of the Safe Use Initiative. “If we can reduce injury that occurs because people are not prescribing or taking medications optimally, we can improve their individual health and the health of the public.”

In its regulatory role, FDA has always tried to prevent medication errors, says Weiss. “A lot of what we do at FDA to reduce medication errors is because we have the authority from Congress to regulate drugs, drug labeling, and drug manufacturing standards.”

But the Safe Use Initiative is different, says Weiss, because it involves collaborations with other parts of the health care industry and professions—besides drug manufacturers and distributors—to reduce harm in ways that do not require regulation. Potential collaborators include

physicians, nurses, and other health care professionals and their professional societiesstate and federal agenciespharmacies, hospitals, and other health care facilitieshealth insurerspatients, caregivers, consumers, and groups representing their interests

FDA continues to add opportunities for collaboration to its growing list of projects that could reduce preventable harm from medicines. Two such opportunities are

to support and assist in the removal of abbreviations on prescription container labelsto support efforts to educate patients about the misuse and abuse of prescription drugs

Although FDA regulates prescription drug labeling—the printed material that accompanies such drugs—individual states regulate the label that the pharmacist attaches to the pill bottle. FDA is working with pharmacies, medical standards organizations, and others to set standards for this bottle label, such as spelling out the full name of a prescription drug instead of using an abbreviation that consumers may not understand.

For example, the prescription form of acetaminophen is often abbreviated “APAP” on the label of the bottle the consumer is given at the pharmacy. If consumers don’t know that “APAP” and “acetaminophen” are the same and are already taking an over-the-counter acetaminophen product (such as Tylenol or another brand), they could be taking too much acetaminophen and accidentally overdose. Too much acetaminophen can cause liver damage.

The Safe Use Initiative team is also working to make consumers aware of the importance of checking drug labels in general because many have the same ingredient—like acetaminophen, which can be found in more than 600 medications.

Another Safe Use Initiative project addresses the taking of prescription drugs when not needed. “About 55 percent of people who misuse or abuse prescription drugs get them from friends and family,” says Dale Slavin, Ph.D., associate director of the Safe Use Initiative.

“We need to create opportunities for discussion between the patient and the doctor,” Slavin says. “We, through collaborative efforts, want to provide tools that the doctor can use to have frank conversations with patients, and tools that the patient can use to understand the benefits, risks, and limitations of their treatment.”

This is especially important for opioid drugs, says Slavin, “where the abuse potential is there, the dependence potential is there, and the potential for others to steal or misuse their drugs is there.”

FDA invites comments and suggestions on drug safety issues and how to prevent harm at cdersafeuseinitia@fda.hhs.gov.

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As headlines from Europe implicate tainted vegetable sprouts in more than 4,000 illnesses and dozens of deaths, American consumers may wonder, “Could that happen here?”

The U.S. has had its own headline-grabbing outbreaks from contaminated vegetables—such as lettuce in 2010, peppers in 2008, and spinach in 2006—but a new law has set in motion sweeping improvements to the safety of our food supply.

President Obama signed the FDA Food Safety Modernization Act into law on Jan. 4, 2011, but the year before, the Food and Drug Administration was already gearing up for important work that was mandated by the act: the Produce Safety Regulation.

This regulation will establish mandatory, science-based, minimum standards for the safe growing, harvesting, sorting, packing, and storage of fresh fruits and vegetables. “This will be a monumental shift in food safety,” says James R. Gorny, Ph.D., FDA’s senior advisor for produce safety.

Since 1998, produce growers have had available the “Good Agricultural Practices” issued by FDA and the U.S. Department of Agriculture (USDA). But this guidance is not an enforceable regulation like the Produce Safety Regulation will be, says Gorny.

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"This will be a monumental shift in food safety."

As part of the regulatory process, FDA publishes a “proposed rule” and then invites comments to the proposed rule “docket” (public record) online or by mail.  Anyone can comment on a proposed rule, and the agency considers all comments submitted to the docket before drawing up the final rule, or regulation. FDA also intends to hold public meetings about the proposed Produce Safety rule after it is published, to provide additional opportunities for the public to comment. The agency expects to publish a proposed Produce Safety rule by spring 2012.

Due to the diversity of produce farms throughout the country—ranging from a few acres to thousands of acres, and growing from a few crops to dozens of vegetable varieties—FDA decided to reach out to growers before drafting the proposed rule.

In 2010, technical experts, scientists, and other staff from FDA and USDA went on the road to meet with growers as well as produce industry groups, public policy groups, state agricultural departments, and public health departments in 13 states. They toured farms—both big and small—and talked to the owners. Some of the farm tours were attended by FDA leadership, including FDA Commissioner Margaret A. Hamburg, M.D., and Deputy Commissioner for Foods Michael R. Taylor, J.D. At the invitation of FDA, USDA Deputy Under Secretary for Marketing and Regulatory Programs Ann Wright joined several of the tours as did a number of state commissioners of agriculture. 

“Before we put pen to paper, we wanted to find out what growers are doing now and the food safety challenges they face,” says Gorny.

“It was a very refreshing change in the process that was welcomed by the growers and that allowed them to be a part of the process,” says Bob Jones, Jr., co-owner and production manager of the Chef’s Garden, a 300-acre farm in Huron, Ohio.

“The Ohio growers, in general, have a great appreciation and understanding of the necessity of good food safety,” says Jones, who also serves on the board of several agricultural associations in the state. “We have a social responsibility to consumers who purchase and consume the food we grow.”

Several themes emerged from the visits, says Gorny. Many growers commented that produce safety standards should

be appropriate and flexiblebe science-based and risk-basedbe practical—not overly burdensomeapply to both imported produce and domestic producebe accompanied by a strong education and outreach program

The agency is working to create a regulation that will be flexible and appropriate for both large-farm operators and smaller farmers—including sustainable, organic, and Amish farmers FDA met when touring the country.

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“One of the themes we heard over and over is ‘educate before you regulate,’” says Gorny.

FDA doesn’t make produce safer, he adds. “We make the rules that must be followed to keep produce safe. So we need to assist growers with knowledge and training to comply with those rules.”

FDA is exploring partnerships with state agricultural departments and extension services, produce industry groups, and coalitions such as the Produce Safety Alliance—a collaboration between Cornell University, USDA, and FDA—to reach out to growers and provide them with training regarding on-farm produce safety.

Jones says everybody who handles food—growers, packers, transporters, processors, grocers, and consumers—has an important part to play in food safety. “You can educate growers on all they can do in the field—for instance, with water quality and worker hygiene—to lower the likelihood of microbial contamination,” he says. But it won’t be effective unless all the other food handlers practice food safety, too.

The bottom line, says Gorny, is that FDA wants American consumers to be able to buy healthful fruits and vegetables with the utmost confidence in their safety.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

 

When the Food and Drug Administration allowed silicone gel-filled breast implants back on the market in November 2006, the agency required the manufacturers to conduct follow-up studies to learn more about the long-term performance and safety of the devices.

Today, FDA released a report that includes preliminary safety data from these studies, as well as other safety information from recent scientific publications and adverse events reported to FDA.

FDA approved silicone gel-filled breast implants for increasing breast size (augmentation) in women age 22 or older and for reconstruction (after breast cancer surgery or other medical issues) in all women. They are also approved for revision surgeries, which correct or improve the result of an original augmentation or reconstruction surgery.

Almost five years later, FDA’s report continues to support the safety and effectiveness of these implants when used as intended, but states that women should fully understand the risks before considering getting them.

Breast implants are not lifetime devices. The longer a woman has them, the more likely she is to have complications and need to have the implants removed or replaced. Women with breast implants will need to monitor their breasts for the rest of their lives.The most frequently observed complications and adverse outcomes are tightening of the area around the implant (capsular contracture), additional surgeries, and implant removal. Other complications include a tear or hole in the outer shell (implant rupture), wrinkling, uneven appearance (asymmetry), scarring, pain, and infection.Studies to date do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, no study has been large enough or long enough to completely rule out these and other rare complications.

FDA is working with the two manufacturers who make silicone gel-filled breast implants, Allergan and Mentor, to address the challenges in collecting follow-up data on the women who have received these implants.

“It is important that women with breast implants who experience any symptoms see their health care providers,” says Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “Women who have enrolled in clinical studies should continue to participate so that we can better understand the long-term performance of these implants and identify any potential problems.”

FDA also provided other information today on both silicone gel-filled and saline-filled breast implants:

FDA recommends that women with silicone gel-filled breast implants do the following:

Follow up. Continue to routinely follow up with your health care provider. Get routine MRIs to detect a rupture that you may not be aware of (silent rupture).  FDA recommends that women with silicone gel-filled breast implants get screenings for silent ruptures three years after they get implants and every two years after that.Be aware. Breast implants are not lifetime devices. The longer you have breast implants, the more likely you are to have complications. One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as 1 in 2 will require removal within 10 years of implantation.Pay attention to changes. Notify your health care provider if you develop any unusual signs or symptoms. Report any serious side effects to the breast implant manufacturer and MedWatch, FDA’s safety information and adverse event reporting program. Report online at http://www.fda.gov/medwatch/index.html or by calling 800-332-1088.Stay in touch. If you’re enrolled in a manufacturer-sponsored study, continue to participate. These studies are the best way to collect information about the long-term rates of complications.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products. 

 

The Food Safety Modernization Act (FSMA), signed into law by President Obama in January, has been called “historic” because it puts the focus of the Food and Drug Administration (FDA) on prevention—working to ensure that unsafe foods are not distributed in the first place.

FDA Commissioner Margaret A. Hamburg says the law directs the agency to oversee food safety in a way that applies “the best available science and good common sense to prevent the problems that can make people sick.”

What lends the new law additional importance is that it provides FDA with new enforcement and inspection authorities.

“These new authorities are critical for the law’s success,” said Michael R. Taylor, FDA’s deputy commissioner for foods. “They give the food companies strong additional incentives for keeping their products safe, and that helps us achieve the new law’s goal, which is to protect consumers from unsafe food.”

Foodborne outbreaks are a significant public health burden that increases the cost of the nation’s health care and, as Taylor has emphasized, many of them can be prevented. And keeping foodborne outbreaks from happening in the first place is what FDA intends to do by implementing the following key provisions:

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Expanded administrative detention: The law gives FDA more authority to prevent the release into the marketplace of adulterated or misbranded food, including potentially harmful food.

Food adulteration can be caused by many factors, including bacterial or chemical contamination, filth or decomposition, the presence of an unsafe food additive, being prepared, packed or held under insanitary conditions, and leaving valuable materials out of the product or substituting other, inferior materials.

Misbranding food can be caused by ways that include not declaring certain ingredients or major food allergens, and not complying with nutrition information content on labeling.

This tool allows FDA to effectively remove the food from distribution channels while the agency pursues legal or other enforcement actions.

Records inspection: The law expands FDA’s authority to gain access to records about potentially hazardous foods. In addition to examining the records tied to a particular food that could pose a health hazard, the agency can now inspect records related to any other food it believes is likely to be affected in a similar manner. Authority to deny entry: Under FSMA, if a food producer in another country does not permit FDA to inspect its facility, FDA can refuse to allow food from that facility into the United States.

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The new law also strengthens FDA’s enforcement tools in the event that potentially unsafe food has already entered the marketplace.

Suspension of registration: The law authorizes FDA to suspend the registration of a facility under certain circumstances if the food it manufactured, processed, packed, received or held presents a serious health hazard. A facility with a suspended registration will not be able to legally offer food for sale in the United States until FDA lifts the suspension.Mandatory recall: Before FSMA, FDA had to rely on a firm’s voluntary decision to remove food from the marketplace that could be hazardous to humans or animals. Under the new law, the agency can order a recall if the company does not cease distribution itself and recall its product. If there is reason to believe that the food is adulterated or misbranded and that use of the product could result in serious illness or death, FDA can order that distribution be halted and all implicated products recalled. Additionally, FDA has launched a new search engine where consumers can quickly and easily check on new and recent recalls.

FDA is also directed by the law to upgrade its ability to track both domestic and imported foods. To do this, FDA will establish pilot projects to test how to rapidly identify recipients of food—this is critical information FDA needs to rapidly find the source of a foodborne outbreak and to understand its scope.

“Product tracing doesn't prevent an outbreak, as it’s more about response,” says Bill Correll at FDA’s Center for Food Safety and Applied Nutrition.  “However, it can prevent further illnesses during an outbreak when FDA can determine the source, contain further exposure and get the product recalled and out of distribution and consumer households.”

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The new FDA authorities have been widely acclaimed by consumer advocates as well as industry.

Caroline Smith DeWaal, the veteran food safety director of the Center for Science in the Public Interest, has hailed FSMA as a far-reaching improvement over previous food safety laws.  "The bill contains important provisions for prevention, standard setting and enhanced enforcement.  It will significantly reinforce the FDA's food safety program," she predicts, "and help the agency advance in its public health mission."

Kathy Means, vice president of the Produce Marketing Association, said that members of her organization “regard FSMA as a law that takes a good, comprehensive look at food safety. It sets the expectations for food safety measures by the industry, and it sets the priorities for the FDA—all of which is important for keeping our food safe.”

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

August 10, 2011

 

Water, bugs, and the sun, are a few of the things kids experience more of in the summertime. For parents and others, extra vigilance is required to prevent injury and keep kids safe and healthy.

Water, bugs, and the sun, are a few of the things kids experience more of in the summertime. For parents and others, extra vigilance is required to prevent injury and keep kids safe and healthy. Here are a few tips to help parents practice prevention, for their children's health.

Keep kids' safe – home alone.
Every parent eventually faces the decision to leave their child home alone for the first time. Whether you are just running to the store for a few minutes or are working moms and dads, parents need to be sure their children have the skills and maturity to handle situations safely. Children face real risks when left unsupervised. Those risks, as well as a child's ability to deal with challenges, must be considered.

Prevent cyberbullying.
Youth can use electronic media to embarrass, harass or threaten their peers through email, a chat room, instant messaging, a website (through blogs), or text messaging. Increasing numbers of teens and pre-teens are becoming victims of this new form of violence. Like traditional forms of youth violence, electronic aggression is associated with emotional distress and conduct problems at school. Learn strategies for protecting children from this type of violence.

Keep your kids tobacco free.
Despite the impact of movies, music, and TV, parents can be the GREATEST INFLUENCE in their kids' lives. Talk directly to your child about the risks of tobacco use; if friends or relatives died from tobacco-related illnesses, let your kids know. If you use tobacco, you can still make a difference. Your best move, of course, is to try to quit. Meanwhile, don't use tobacco in your children's presence, don't offer it to them, and don't leave it where they can easily get it.

Talk early and often about alcohol and drugs.
Start having conversations about your values and expectations while your child is young. Your child will get used to sharing information and opinions with you. Knowing the facts will help your child make healthy choices.

Prevent teen dating violence
Did you know that in the past 12 months, one in 10 teens report being hit or physically hurt on purpose by a boyfriend or girlfriend at least once? And nearly half of all teens in relationships say they know friends who have been verbally abused.  Dating violence can have a negative effect on health throughout life. Victims of teen dating violence are more likely to do poorly in school, and report binge drinking, suicide attempts, physical fighting and current sexual activity. Before violence starts, a teen may experience controlling behavior and demands. That's why adults need to talk to teens now about the importance of developing healthy, respectful relationships.

Know asthma triggers [PDF - 2.15 MB].
An asthma attack is when you have trouble catching your breath. Many different asthma "triggers" can cause this to happen. Knowing some common triggers such as tobacco smoke, dirty air outside, bad weather, and hard exercise that makes you breathe fast can prevent asthma attacks. Speak with your health care provider about making a plan that can help control your child's asthma.

Develop a family disaster plan.
Meet with your family and discuss why you need to prepare for disaster. Explain the dangers of fire, severe weather, and earthquakes to children. Plan to share responsibilities and work together as a team. Discuss the types of disasters that are most likely to happen. Explain what to do in each case.

Water safety.
When most of us are enjoying time at the pool or beach, injuries aren't the first thing on our minds. Yet, drownings are the leading cause of injury death for young children ages 1 to 4, and three children die every day as a result of drowning. Parents can play a key role in protecting children from drowning.

Boat safely.
Recreational boating can be a wonderful way to spend time with family and friends. Making boating safety a priority can ensure that it stays fun. By wearing a life jacket, you can dramatically decrease your chances of drowning while boating.

Child Passenger Safety: Make sure the ones you love are safe and secure—all the time, on every trip.
In 2008, about 4 children ages 14 or younger were killed in motor vehicle crashes every day, and many more were injured. But parents and caregivers can make a lifesaving difference. Whenever you're on the road, make sure your child passengers are buckled into appropriate safety seats. The safest place for children of any age to ride is properly restrained in the back seat. Children ages 12 and younger should always be buckled up and seated in the rear seat of vehicles. Infants in rear-facing car seats should never ride in the front seat of vehicles with airbags. Learn all you can do to keep your most precious cargo safe and locate a car inspection station in your area.

Play it Safe. Prevent concussions.
There are things you can do to help lower the risks for concussion and other injuries. A concussion is a type of traumatic brain injury, or TBI, caused by a bump, blow, or jolt to the head that can change the way your brain normally works. Concussions can also occur from a fall or a blow to the body that causes the head and brain to move quickly back and forth. Concussions can occur in any sport or recreation activity. Learn concussion signs and symptoms and what to do if a concussion occurs.

Prevent falls.
Falls are the leading cause of non-fatal injuries for all children ages 0 to 19. Every day, approximately 8,000 children are treated in U.S. emergency rooms for fall-related injuries. This adds up to almost 2.8 million children each year. Many falls can be prevented, and parents and caregivers can play a key role in protecting children.

Prevent burns.
Every day, 435 children ages 0 to 19 are treated in emergency rooms for burn-related injuries and two children die as a result of being burned. Younger children are more likely to sustain injuries from scald burns that are caused by hot liquids or steam, while older children are more likely to sustain injuries from flame burns that are caused by direct contact with fire.
Thankfully, there are ways you can help protect children from burns.

Keep teen drivers safe.
Discuss your rules of the road with your teen. Talk about why they are important to follow, as well as consequences for breaking the rules. Work with your teen to draft and sign a parent-teen driving agreement. You may choose to hang yours on the refrigerator door to highlight the importance of safe driving. Let your teen know that following the rules and driving safely will result in greater driving privileges.

Prevent childhood lead poisoning.
Lead poisoning is entirely preventable. The key is stopping your child from coming into contact with lead and treating children who have been poisoned by lead. Lead-based paint and lead contaminated dust are the main sources of exposure for lead in U.S. children. Learn ways to reduce children's exposure to lead poisoning.

Prevent too much sun.
Just a few serious sunburns can increase your child's risk of skin cancer later in life. Kids don't have to be at the pool, beach, or on vacation to get too much sun. Their skin needs protection from the sun's harmful ultraviolet (UV) rays whenever they're outdoors.

Have a healthy home.
Stay smart around the house. Get smart tips on fire prevention, microwave use, and living with pets. Parents can also take many actions to protect their children's health and safety. At a very young age, children develop the habits and behaviors that will influence their lifelong health.

Keep cool in the heat.
Take steps to prevent heat-related illnesses, injuries, and deaths during hot weather. People who are at highest risk are the elderly, the very young, and people with mental illness and chronic diseases. But even young and healthy people can get sick from the heat if they participate in strenuous physical activities during hot weather. Never leave infants, children or pets in a parked car, even if the windows are cracked open.

Be active.
Youth gain physical and mental health benefits when they participate in regular physical activity. Regular physical activity in childhood and adolescence improves strength and endurance, helps build healthy bones and muscles, helps control weight, reduces anxiety and stress, increases self-esteem, and may improve blood pressure and cholesterol levels. Positive experiences with physical activity at a young age also help lay the basis for being physically active throughout life.

Eat healthy foods.
You can help children learn to be aware of what they eat by developing healthy eating habits, looking for ways to make favorite dishes healthier, and reducing calorie-rich temptations. To help your child maintain a healthy weight, balance the calories your child consumes from foods and beverages with the calories your child uses through physical activity and normal growth.

Get immunizations.
Vaccines aren't just for babies. As kids get older, the protection provided by some of the vaccines given during childhood can begin to wear off. Older kids can also develop risks for certain infections as they enter the preteen and teen years. The preteen and teen vaccines not only help protect them, but also their friends, community and family members. Also, make sure that children's vaccinations are up to date. When traveling with children, outside of the country and for recommendations for specific countries, don't forget to check the destinations  page for the region you are traveling to.

Make a plan to help your child manage diabetes at school. Start by meeting with school staff and by making sure your child has the necessary supplies for routine care and blood sugar emergencies.

You may already have bought the basic school supplies for sending your child back to school. But if your child has diabetes, you need to make additional preparations.

A person with diabetes must manage this chronic illness all the time, including during the school day.  Staff such as nurses, teachers and coaches can work with you and your child on managing diabetes. This assistance may include helping your child take medications, check blood sugar levels, choose healthy foods in the cafeteria, and be physically active.

To help your child get ready for the first day of school and for the rest of the school year, here are a few key tips:

Meet with staff early in the school year to learn more about how the school helps students care for diabetes and handles any diabetes-related emergencies. Public schools and schools that receive federal funding are prohibited from discriminating against people with diabetes by the Americans with Disabilities Act and Section 504 of the Rehabilitation Act.  You can work with your child's doctor and school staff to create a Diabetes Medical Management Plan. Having a plan helps your child and school workers with managing diabetes in school and during extracurricular activities. Be sure to include information on services the school will provide and how to recognize high and low blood sugar levels. Your child may need assistance with giving insulin and checking blood sugar levels, and also may need to eat snacks in the classroom. For more information, visit Helping the Student with Diabetes Succeed: A Guide for School Personnel.

Your child must have access to supplies needed to manage diabetes and to treat any episodes of high or low blood sugar. You and your child can work together to create a care package to bring in his or her backpack. Supplies should include:

blood glucose meter, testing strips, lancets, and extra batteries for the meterketone testing suppliesinsulin and syringes/pensantiseptic wipesglucose tablets or other fast-acting glucose snackwaterfor children who wear an insulin pump, backup insulin and syringes/pens in case of pump failure

Also, be sure school workers have a glucagon emergency kit and know how to use it if your child experiences a low blood sugar emergency.

If your child is going to monitor his or her blood sugar, ensure that he or she feels comfortable doing so. If a trained school employee will do the monitoring, be sure your child knows where and when to go for testing. Also, make sure your child knows who to go to for help with high or low blood sugar episodes. The actions to be taken should be in the Diabetes Medical Management Plan.

Prepare a healthy breakfast, which will help your child stay focused and active. If you send a lunch with your child, pack a healthy meal that contains whole grains and fresh fruits and vegetables. Replace high-fat foods with low-fat options, such as low-fat turkey, reduced-fat cheese, and skim milk. Include healthy snacks, such as fruit, nuts or seeds, which your child can eat later in the day to help avoid the vending machine and keep blood sugar under control. If your child buys meals at school, look at the cafeteria menus together to help him or her make choices that fit into a healthy meal plan. Many schools post their menus online, or you can request this information from school workers.

Having diabetes does not mean that your child cannot be physically active or participate in physical education classes.  In fact, being active can help your child improve his or her blood sugar control. Also, limit screen time – TV, videogames and the internet – to one to two hours a day. Being active at an early age establishes good habits for a lifetime and is a lot of fun. Encourage your child by being active together, doing such things as walking the dog, riding bicycles or playing basketball, and you will get the health benefits too.

Check to be sure your child has had all recommended vaccinations, including the flu shot. If children with diabetes get sick, they can take a longer time to recover than children without diabetes. Talk to your child's doctor to see if your child needs any vaccinations before starting the school year. Also, encourage your child to wash his or hands regularly, such as before eating and after using the bathroom.

Diabetes does not have to get in the way of your child's good experience at school. Remember, parents and schools have the same goal: to ensure that students with diabetes are safe and that they are able to learn in a supportive environment. Make sure school staff have the information and resources they need for your child's safety and health. Help prepare your child to manage diabetes when he or she goes back to school.

CDC works 24/7 saving lives, protecting people from health threats, and saving money to have a more secure nation. A US federal agency, CDC helps make the healthy choice the easy choice by putting science and prevention into action. CDC works to help people live longer, healthier and more productive lives.

After declining 2% between 2007 and 2008, birth rates for 15- to 19-year-olds decreased again between 2008 and 2009 for all races and for Hispanics. This indicates that the steady decline in teen birth rates from 1991 through 2005 has resumed, after briefly increasing between 2005 and 2007. In 2009, 409,840 live births occurred to mothers aged 15-19 years, a birth rate of 39.1 per 1,000 women in this age group (down from 434,758 births and a birth rate of 41.5 in 2008). The Hispanic, American Indian/Alaska Native, and non-Hispanic black teen pregnancy rates are more than twice as high as the non-Hispanic white teen birth rate.(1)

The teen birth rate for 15–19 year olds decreased 6% between 2008 and 2009. Rates decreased for all races, including 4% for non-Hispanic whites, 6% for non-Hispanic blacks, 5% for American Indian/Alaska Natives, 10% for Asian American/Pacific Islanders. The Hispanic teen birth rate decreased almost 10%.(1) During this time period, birth rates declined for all age groups except among women age 40 years and older.(1)

Underlying causes for the decreases are not yet known, and it is unclear whether they will continue. While birth rates for other age groups have also decreased during this time, teen birth rates bear concern due to the potential increase in the socioeconomic burden of teen pregnancy and childbearing. Teen birth rates in the U.S. remain up to nine times higher than in most other developed nations. In general, factors associated with teen pregnancy and childbearing include:

Being sexually active(2)Lack of access to or poor use of contraception(2)Living in poverty(3)Having parents with low levels of education(3)Poor performance in school(3)Growing up in a single-parent family(3)

As part of the President's Teen Pregnancy Prevention Initiative (TPPI), CDC is partnering with the federal Office of the Assistant Secretary for Health (ASH) to reduce teenage pregnancy and address racial, ethnic, and geographic disparities in teen pregnancy and birth rates. The ASH Office of Adolescent Health (OAH) is supporting public and private entities to fund medically accurate and age appropriate evidence-based or innovative program models to reduce teen pregnancy. For more information please visit Teenage Pregnancy Prevention: Integrating Services, Programs, and Strategies Through Communitywide Initiatives. 

Hamilton BE, Martin JA, Ventura SJ. Births: Preliminary data for 2009. National vital statistics reports; vol 59 no 3. Hyattsville, MD: National Center for Health Statistics. 2010. Table 2.Ventura SJ, Abma JC, Mosher WD, Henshaw SK. Estimated pregnancy rates by outcome for the United States, 1990-2004. National vital statistics reports; vol 56 no 15. Hyattsville, MD: National Center for Health Statistics. 2008.Singh S, Darroch JE. Adolescent pregnancy and childbearing: levels and trends in developed countries. Family Planning Perspectives 2000;32(1):14–23.CDC works 24/7 saving lives, protecting people from health threats, and saving money to have a more secure nation. A US federal agency, CDC helps make the healthy choice the easy choice by putting science and prevention into action. CDC works to help people live longer, healthier and more productive lives.

If your heart rhythms do not occur normally, then it can be a result of improper electrical signals being conducted to the heart because of defective cell or tissue pathways. Though the cause of this abnormality might not be clear at times, but conditions like atrial tachycardia, atrial flutter or supraventricular tachycardia can be treated with the help of a procedure called a cardiac ablation. If you are suffering from any cardiac dysfunction and looking for information on what is Cardiac Ablation, then read on.

When you go through the process of cardiac ablation, then the electrophysiologist carries out a cardiac catheterization that is responsible to send radio frequencies to the cells or tissues that are responsible for creating the abnormal heart rhythms. This radio frequency in turn destroys the cells or tissues that are creating problem, so that they are no longer able to transmit the improper signals that are causing arrhythmia.

In cases where the cardiac ablation is seen to be successful, it can also able to prevent the irregular heartbeats and bring back the proper functioning of the heart rhythm. However, the process of cardiac ablation does involve some risks. It is quite a possibility that radio frequency might cause damage to the normal cells and tissues and the same holds true for the catheter tip. It is seen in some cases that when people undergo this process of cardiac ablation, they end up needing a pacemaker. This however is seen in people who might not get any signals to their heart to help it beat normally.

The other considerable risks might include bruising or bleeding of the area where the catheter tip is inserted. Usually, the groin is used for insertion of the catheter and this can also lead to a possible infection; though the practitioner performing the test would take enough precautions to avoid and bruise or infection. Some of the rare complications that can develop as a result of the cardiac ablation include stroke, which can occur in case the catheter touches a blood clot which can find its way to the blood stream. This however is a rare risk seen as negligible in most cases.

The process of cardiac ablation usually only takes a couple of hours. However, the process can take up to six hours for the entire process. This process is conducted only if the physician feels that it would be effective for a particular patient. Usually, cardiac ablations are an outpatient process, but at times the doctor might want you to stay over night for observation in case any side effects occur and also for checking the improvement that the procedure has resulted in. You will have to visit the doctor frequently to have your cardiac rhythm analyzed so that the doctor can determine the progress.

The success rate of cardiac ablation has been recorded up to 90% in cases of defective atrial rhythm. The process seems to be less promising in case of abnormal ventricular rhythms, but still almost 70-80% of the cases resulting from ventricular tachycardia can be cured with the help of cardiac ablation. These days, cardiac ablation is being preferred as a good option before moving to surgical treatments.

Metabolic syndrome is a cluster of conditions that occur together, increasing the risk of heart disease, stroke and diabetes. Conditions like increased blood pressure, elevated insulin levels, excess body fat around the waist or abnormal cholesterol levels are not diagnosed as metabolic syndrome, but they do contribute to the risk of a serious disease. If more than one of these conditions occur in combination, the risk is even greater.

Having metabolic syndrome means one has several disorders related to the metabolism at the same time, including:

ObesityHigh blood pressureHigh triglycerides and low level of high-density lipoprotein (HDL) cholesterol (also called the good cholesterol)Resistance to insulin, a hormone that helps to regulate the amount of sugar in your body

Risk Factors:

The following factors increase the chances of developing the metabolic syndrome:

1. Age – the prevalence of metabolic syndrome increases with age.
2. Race – hispanics and Asians seem to be at a greater risk of metabolic syndrome than other races.
3. Obesity – a body mass index greater than 25 increases the risk of metabolic syndrome. So does abdominal obesity; having an apple shape rather than a pear shape.
4. History of diabetes, one is more likely to have metabolic syndrome if there is a family history of type 2 diabetes or a history of diabetes during pregnancy.
5. Other diseases – a diagnosis of high blood pressure, cardiovascular disease or polycystic ovary syndrome also increases the risk of metabolic syndrome.

Aggressive lifestyle changes and, in some cases, medication can improve all of the metabolic syndrome components. Getting more physical activity, losing weight and quitting smoking helps reduce blood pressure and improves cholesterol and blood sugar levels. These changes are key to reducing the risk.

Exercise: 30 to 60 minutes of moderate intensity exercise, such as brisk walking, every day.
Lose weight: losing as little as 5 percent to 10 percent of body weight can reduce insulin levels and blood pressure and decrease your risk of diabetes.
Eat healthy: a diet that limits unhealthy fats and emphasises fruits, vegetables, fish and whole grains is ideal.
Stop smoking: smoking cigarettes increases insulin resistance and worsens the health consequences of metabolic syndrome.

It is important to monitor weight and blood glucose, cholesterol and blood pressure levels to ensure that lifestyle modifications are working. If you are not able to achieve your goals with lifestyle changes, medications may be prescribed to lower blood pressure, control cholesterol or help you lose weight.

Prevention:

Whether one has one, two or none of the components of metabolic syndrome, the following lifestyle changes will help reduce the risk of heart disease, diabetes and stroke:

1. A healthy diet – eat plenty of fruits and vegetables. Avoid processed or deep-fried foods. Eliminate table salt and experiment with other herbs and spices.
2. Get moving – get plenty of regular, moderately strenuous physical activity.
3. Schedule regular checkups – Check your blood pressure, cholesterol and blood sugar levels on a regular basis.

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There has been a lot of talk recently about informed consent regarding surgical procedures. Most of this talk has been centered around the spate of cases involving unnecessary stent placement. While informed consent is a wonderful thing especially when the patient has time to digest what information they have been given, it can work against the patient as well when time is of the essence. Unfortunately when the patient is in an emergency situation such as having a heart attack, informed consent falls by the wayside.

When I had my heart attack back in 2009 everything seemed to happen so fast as soon as I entered the emergency room. As soon as I told the admitting nurse what was going on with me, IE chest discomfort and a shooting pain in my jaw, I was immediately taken to a room where my shirt was taken off and an EKG started. No less than 2 doctors were present and while one was administering the EKG another was taking blood. The EKG showed a minor anomaly but before they could re-administer the test the other doctor returned with the news that there were enzymes in my blood, I had had a heart attack.

The doctor informed me that an ambulance was waiting and I would be taken to the hospital down the street because they had a cardiac catheterization lab ( cath lab ) where I would receive the care that I needed. I was confused and very scared at this point and all the previous actions happened in the span of just 15 minutes.

When I reached the new hospital I was taken from the ambulance and rolled no more than 50 feet into the hospitals cath lab, which was already full of people waiting for me. As soon as I was in the lab IV’s were started and the operating doctor was standing over me. He quickly explained the catheterization process. An incision would be made on my inner thigh and a catheter with a small camera would be threaded through my femoral artery up to my heart, where they would begin the process of searching for the blockage.

While all the doctors in my case were very good at informing me of what was going on and what they were doing to help me there wasn’t time for them to explain every nuance of the procedures or give me an extensive history of the drug eluting stents they placed in my artery , not to mention the fact that I had never heard of a stent before and would have gone with the doctors decision anyway as he knows best, right?

Here’s the real problem when it comes to informed consent in an emergency, I was alone, scared and my mind was racing a million miles hour, even if there was time for the doctors to explain the pro’s and con’s of stenting and drug eluting stents I wouldn’t have digested that information in a rational way…I was having a heart attack! I knew nothing about the catheterization procedure or the stents used and as far as anyone knew time was ticking and I could have another heart attack at any second.

In cases such as this informed consent is almost meaningless but the after care is of paramount importance. After the emergency is over the doctor needs to sit with you and explain in detail what took place, what procedures were used, what devices were used or implanted and the significance of this is on your health and life.All your questions need to be answered in a setting where you are ready to digest all the information.

Because the recent problems concerning what some believe as unnecessary stenting in several states there is now a call for better informed consent before beginning these procedures. While I agree that informed consent is a good thing in most cases, in an emergency such as a heart attack there just isn’t time and the patient would unlikely understand what was being said even if they knew beforehand about stents and catheterizations.

I believe the majority of medical professionals have your best interest at heart and they also have the knowledge that we as laypeople don’t. If you are having a kidney stone removed then by all means informed consent is a blessing, when you are having a heart attack informed consent could kill you.