FDA’s MedWatch Safety Alerts: April 2013

FDA’s MedWatch Safety Alerts alert consumers to problems with quality or safety of medical products. The April listing includes products such as anti-seizure medications, multivitamin supplements, mattress covers, blood glucose meters and compounded drugs.

Consumer Update Analytics

This page contains the most recent Consumer Update data available and links to past Consumer Update Analytics web pages.

Stay Safe in the Summer Sun

FDA has taken steps on multiple fronts to protect consumers from the skin damage that can be caused by too much exposure to the sun. This is the first summer in which FDA's new rules governing sunscreen labeling are in effect. And FDA is supporting "Don’t Fry Day" on May 24.

FDA's Role in Regulating Safety of GE Foods

GMOs, genetically modified organisms, biotech foods, or genetically engineered foods - whatever name they're called - seem to be a captivating topic. Learn more about them and how they are regulated in this FDA Consumer Update.

Pregnancy: A Time for Special Caution

Pregnant and breastfeeding women can turn to FDA's Office of Women's Health for important health information, including details about the risks and benefits of taking medication during this special time.

Keep Listeria Out of Your Kitchen

Keep Listeria at bay by keeping your refrigerator temperature low and carefully cleaning kitchen surfaces.

Know the Risks of Indoor Tanning

Exposure to ultraviolet (UV) radiation - whether outdoors from the sun, or indoors under a sunlamp - causes damage to your skin, including skin cancer. Find out how FDA is proposing to change how it regulates sunlamps, including requiring labeling recommending that young people not use these devices.

FDA to Investigate Added Caffeine

Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor discusses his concerns about the increasing number of caffeinated products and their impact on children.

Fighting the Impact of Antibiotic-Resistant Bacteria

David White, chief science officer in FDA's Office of Food and Veterinary Medicine, and Edward Cox, director of FDA's Office of Antimicrobial Products, explain the efforts FDA is making to combat the public health impact of antibiotic-resistant bacteria.

Clinical Trials Shed Light on Minority Health

FDA is working to increase minority participation in the clinical trials that test new medical products. Members of minority groups are move vulnerable to certain diseases, but are under-represented in these trials.

FDA Invention Fights Counterfeit Malaria Drugs

A tool invented by FDA scientists is being deployed in a partnership to fight counterfeit malaria drugs. Testing is planned in Ghana. More than a third of malaria drugs in Sub-Saharan Africa and Southeast Asia are counterfeit or substandard.

FDA Wants YOU (to Get Involved)

FDA's Patient Liaison Program helps to bring the unique perspective of patients, family members, caregivers and patient advocates to the decision-making processes of the FDA. Learn the many ways you can get involved and become part of the process that regulates food and drugs.

Making Health and Health Care Equal for All

At FDA, achieving equality in health and health care is part of the mission of the Office of Minority Health. The office was established in 2010 to help the agency address the needs of Americans who may be more vulnerable because of their race, ethnicity or other factors.

FDA Wants Your Opinion on Dairy-Product Labels

FDA is inviting consumer comments on a petition from two dairy industry groups to change the standard of identity for flavored milk and 17 other dairy products. This would make it possible for manufacturers of some artificially sweetened dairy products to avoid stating that fact on the front of their packaging.

Stimulant Potentially Dangerous to Health, FDA Warns

FDA's efforts to get dietary supplements containing the stimulant DMAA off the market illustrates the agency's role in regulating dietary supplements and serves as a warning to consumers.

Zebrafish Make a Splash in FDA Research

At the Food and Drug Administration's National Center for Toxicological Research in Arkansas, scientists are using zebrafish as models for studying how certain drugs could affect humans. See how these tiny, transparent fish may make a difference to your health someday.

Nicotine Replacement Therapy Labels May Change

FDA finds that labels on over-the-counter nicotine replacement therapy products can be changed to allow consumers to use them longer and at the same time as other nicotine-containing products.

Temporary Tattoos May Put You at Risk

Are temporary tattoos just a little harmless fun? Not necessarily, say FDA experts. Learn the potential dangers of temporary tattoos made with henna ink and how they have sent many people to the emergency room.

Putting a Patch on Migraines

Migraines affect more than 30 million Americans. Learn about what causes migraines, the newest, FDA-approved form of migraine treatment—a patch—as well as other treatments and things you can do to prevent these painful headaches.

March 19 Webinar: The Dangers of Purchasing Drugs Online

Skip those “Law and Order” reruns. Listen to the real thing when an FDA special agent discusses how criminals selling counterfeit drugs online to U.S. consumers are brought to justice. Click here [www.fda.gov/AboutFDA/Transparency/Basics/ucm343200.htm] to find out how to connect to this 30-minute webinar.

FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy

The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these products should not be administered to patients.

FDA seeks preliminary injunction against New York fish manufacturer

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA), is seeking a preliminary injunction in the U.S. District Court for the Eastern District of New York against New York City Fish, Inc., and several key employees for manufacturing and distributing ready-to-eat fish products under insanitary conditions causing them to become adulterated.

FDA approves Simponi to treat ulcerative colitis

The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.

FDA approves new drug for advanced prostate cancer

The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

FDA approves Nymalize--first nimodipine oral solution for use in certain brain hemorrhage patients

On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule.

FDA approves first companion diagnostic to detect gene mutation associated with a type of lung cancer

The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC).

FDA releases new tool to help prevent intentional food contamination

The U.S. Food and Drug Administration has released a new tool to help bolster the food industry’s defense measures against an act of intentional food contamination. The Food Defense Plan Builder is a comprehensive, easy-to-use software program designed to help owners and operators of food facilities—ranging from primary production and manufacturing to retail and transportation—develop customized plans to minimize the risk of intentional contamination at their individual food facilities.

FDA warns consumers about potential health risk with Juices Incorporated juice products

The U.S. Food and Drug Administration is warning consumers not to consume any juice products or other beverages from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y. The company's carrot and beet juice products have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause botulism, a serious and potentially fatal foodborne illness. Consumers are warned not to consume these products even if they do not look or smell spoiled.

FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease

The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.

FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop

The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.

FDA issues proposal to increase consumer awareness of tanning bed risks

Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.

FDA warns pregnant women to not use certain migraine prevention medicines

The U.S. Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium can cause decreased IQ scores in children whose mothers took the medication during pregnancy. Therefore, these drugs are being contraindicated for (should never be used by) pregnant women for the prevention of migraine headaches. Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.

FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older

The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.

FDA approves Procysbi for rare genetic condition

The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare disease or condition.

FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding

The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.

FDA launches partnership to protect against counterfeit anti-malarial medicines with FDA-developed handheld detection tool

The U.S. Food and Drug Administration today announced a public-private partnership to help identify counterfeit or substandard anti-malarial medicines, including falsified products, with the deployment of the FDA-developed Counterfeit Detection Device, called CD-3.

FDA announces voluntary nationwide recall by Balanced Solutions Compounding Pharmacy

Balanced Solutions Compounding Pharmacy (Balanced Solutions), a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, Fla., is voluntarily recalling all lots of its sterile non-expired drug products due to a lack of sterility assurance and concerns with product quality controls.

FDA approves abuse-deterrent labeling for reformulated OxyContin

The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).

FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall

The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that sterile drug products made by ApotheCure, Inc. and sterile lyophilized (freeze dried powder) drug products made by NuVision Pharmacy were produced under conditions that could create a high potential for contamination. These products should not be administered to patients.

FDA: U.S. Marshals seize food at New York-based food facility

U.S. Marshals have seized food products at a Ridgewood, N.Y. warehouse that manufactures and distributes kosher food products, after investigators from the U.S. Food and Drug Administration found widespread rodent infestation in the facility.