FDA

FDA Warns Consumers Not to Use Body Building Products Marketed as Containing Steroids or Steroid-Like Substances
Tue, 28 Jul 2009 13:56:00 -0500

The U.S. Food and Drug Administration today issued a Public Health Advisory (PHA) warning consumers to stop using body building products that are represented as containing steroids or steroid-like substances. Many of these products are marketed as dietary supplements.

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FDA Issues Final Regulation on Dental Amalgam
Tue, 28 Jul 2009 11:33:00 -0500

The U.S. Food and Drug Administration today issued a final regulation classifying dental amalgam and its component parts – elemental mercury and a powder alloy—used in dental fillings. While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients.

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MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA Warns of Health Risks Posed by E-Cigarettes
Thu, 23 Jul 2009 13:15:00 -0500

FDA and other health experts warn consumers about the potential health risks posed by electronic smoking devices.

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Zicam Cold Remedy Nasal Products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size)

Audience: Consumers

FDA notified consumers and healthcare professionals to discontinue use of three Zicam Nasal Gel/Nasal Swab products sold over-the-counter as cold remedies because they are associated with the loss of sense of smell that may be long-lasting or permanent. The FDA has received more than 130 reports of loss of sense of smell associated with the use of the three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products. People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

Read the complete MedWatch 2009 Safety Summary, including links to the Public Health Advisory and Consumer Update page, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

6-16-09
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Nestle Toll House Prepackaged, Refrigerated Cookie Dough
Audience: Consumers, All Healthcare Professionals

FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). The warning is based on an ongoing epidemiological study conducted by the CDC and several state and local health departments. Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome (HUS). No one has died.E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS, which can lead to serious kidney damage and even death.

FDA advises that if consumers have any prepackaged, refrigerated Nestle Toll House cookie dough products in their home that they throw them away. Cooking the dough is not recommended because consumers might get the bacteria on their hands and on other cooking surfaces. Individuals who have recently eaten prepackaged, refrigerated Toll House cookie dough and have experienced any of these symptoms should contact their doctor or health care provider immediately. Any such illnesses should be reported to state or local health authorities.
6-20-09
Read the complete MedWatch 2009 Safety summary including links to the FDA news release and consumer update and the CDC information page, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

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Fun Express Water-based Face Paints for Children
Audience: Consumers, Pediatricians, Dermatologists
FDA is notifying consumers and healthcare professionals of the recall of cosmetic “Face Paint” items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children, including rashes, itchiness, burning sensation, and swelling where the face paints were applied. All exposures occurred on the same day at an organized event in children exposed to various colors of the face paint. Significant microbial contamination was indicated in most of the products in testing by an FDA laboratory. These items were distributed nationwide. See the News Release for a listing of affected products. 5-12-09

Read the complete MedWatch 2009 Safety summary, including a link to the FDA news release, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#Paints

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Hydroxycut Products

Audience: Consumers, healthcare professionals
[Posted 05/01/2009] FDA warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc. Hydroxycut products are associated with a number of serious liver injuries. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

Read the complete MedWatch Safety summary including links to the FDA news release, Q&A's and a listing of all products included in this alert, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#Hydroxycut
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FDA Serves Warrant for Inspection of Westco Fruit and Nuts Inc.
Wed, 08 Apr 2009 09:51:00 -0500

At the request of the U.S. Food and Drug Administration, U.S. Marshals today executed an inspection warrant at Westco Fruit and Nuts Inc. (Westco/Westcott), an Irvington, N.J.-based company. Westco/Westcott did not provide access to distribution documents and declined to recall products after an FDA request. Regulated companies are required by law to grant FDA entry for inspection, as well as provide access to distribution records. The FDA does not have authority to compel companies to recall food products, such as peanuts.

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On the Road Again: FDA's Mobile Laboratories
Mon, 30 Mar 2009 14:57:00 -0500

This article (with slide show) reveals how mobile labs help FDA test food and drugs for contaminants.

webmail@oc.fda.gov

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FDA Issues Early Communication about a Safety Review of Xigris
Wed, 04 Feb 2009 10:29:00 -0600

The U.S. Food and Drug Administration today announced that it is working with the maker of Xigris (drotrecogin alfa activated), Eli Lilly and Company, to further evaluate the incidence of serious bleeding events and death in patients who receive Xigris, a drug used to treat severe sepsis (a blood stream infection).

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FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events
Tue, 10 Feb 2009 11:46:00 -0600

The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released today by the FDA and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and helps better predict an individual’s risk of developing these reactions.

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Meeting of the Science Board to the Food and Drug Administration (February 24)
Fri, 13 Feb 2009 08:13:00 -0600

The Science Board will hear about and discuss updates from the agency on the continued assessment of Bisphenol A (BPA) in FDA-regulated products. The Science Board will hear about the plans for the following: (1) The review of FDA Center’s science programs, (2) the review of each Center’s projects within scientific priority areas, and (3) the handling of biospecimens used for genomic and proteomic analyses. The Science Board will also hear updates from two working groups on economically motivated adulteration of FDA-regulated products and rapid detection of Salmonella in foods.

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FDA Advises Public of Serious Adverse Event with Psoriasis Drug Raptiva
Thu, 19 Feb 2009 12:30:00 -0600

The U.S. Food and Drug Administration today issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients have died. All four patients were treated with the drug for more than three years. None of the patients were receiving other treatments that suppress the immune system.

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FDA notified healthcare professionals that updated clinical data has determined that treatment with zonisamide, indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy, can cause metabolic acidosis in some patients. Patients with predisposing conditions or therapies may be at greater risk for developing metabolic acidosis and the risk of zonisamide-induced metabolic acidosis appears to be more frequent and severe in younger patients. FDA recommends that healthcare professionals measure serum bicarbonate before starting treatment and periodically during treatment with zonisamide, even in the absence of symptoms and is working with the makers of zonisamide to revise the product labeling to reflect this new safety information. The notification includes recommendations for healthcare providers, information for patients, and a data summary. 2/23/09

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The U.S. Food and Drug Administration announced that a facility owned by India-based Ranbaxy Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008.

The FDA is continuing to investigate this matter to ensure the safety and efficacy of marketed drugs associated with Ranbaxy’s Paonta Sahib site. To date, the FDA has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.

In the meantime, the FDA recommends that patients not disrupt their drug therapy because this could jeopardize their health. Individuals who are concerned about their medications should talk with their health care professional.

To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility. The AIP is invoked when a company’s actions raise significant questions about the integrity of data in drug applications. This AIP covers applications that rely on data generated by the Paonta Sahib facility only.

Under the AIP, the FDA has asked Ranbaxy to cooperate with the agency to resolve the questions of data integrity and reliability. This would include implementing a Corrective Action Operating Plan (CAOP) to provide assurance of the integrity and reliability of data from the Paonta Sahib facility. A CAOP includes, but is not limited to, conducting a third-party independent audit of applications associated with Paonta Sahib.

When the AIP is implemented, the FDA stops all substantive scientific review of any new or pending drug approval applications that contain data generated by the Paonta Sahib facility. 2-26-09

For more information, please visit: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01962.html

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http://www.fda.gov/medwatch/safety/2008/dec08.htm

In December 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:

Avandamet, Avandaryl, Myozyme, Arimidex, Avelox, Celebrex, Children's Advil Cold, Crixivan, Delsym, Dianeal, Ethyol, Innohep, Lipofen, OMNICEF, Rifater and Sensipar

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FDA Shuts Down a Flour Tortilla Manufacturer for Repeated Violations
Sat, 07 Mar 2009 02:59:00 -0600

The U.S. Food and Drug Administration (FDA) today announced that Del Rey Tortilleria Inc., Chicago, Ill., its president, and two general managers have entered into a consent decree of permanent injunction that prevents Del Rey Tortilleria from manufacturing and distributing soft-shell flour tortillas until the company obtains FDA approval.

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FDA Issues Guidance on Safe Production of Foods Containing Peanut-Derived Ingredients 3-9-09

The U.S. Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN) today issued guidance to the food industry advising manufacturers that peanuts and peanut-derived products used as food ingredients pose a risk of Salmonella contamination, and recommending measures that manufacturers can take to address that risk for peanut derived products received from their ingredient suppliers and for the products they themselves produce. CFSAN also issued today a companion bulletin to operators of food-service establishments and retail food stores that offer food products containing peanuts and peanut-derived ingredients.

The guidance recommends that manufacturers obtain their peanut-derived ingredients only from suppliers who use production processes that have been demonstrated to adequately reduce the presence of Salmonella, or that they ensure that their own manufacturing process would adequately reduce the presence of Salmonella. The guidance provides information that manufacturers should consider in evaluating their processes.

The bulletin asks retail and food service operations to work with their suppliers to ensure that all peanut-derived products used as ingredients or sold as food have been manufactured and packed in accordance with current good manufacturing practice requirements. Retail and food service operations should take steps to ensure that their suppliers use production processes that have been demonstrated to adequately reduce the presence of Salmonella and should work with their suppliers to ensure that all peanut-derived products used as ingredients or sold as food are not subject to an on-going product recall.

The guidance and bulletin are being issued in the midst of a large, ongoing, multi-state outbreak of consumer illness associated with consumption of food products containing peanut-derived ingredients produced by a single peanut processor. FDA will accept public comments on the guidance. Both the guidance and bulletin were posted today on FDA's website (Peanut-Derived Product Guidance, and Peanut-Derived Product Bulletin) and are scheduled to be published soon in the Federal Register.

FDA is aware that the Grocery Manufacturers Association (GMA), collaborating with other food industry organizations in a Salmonella Control Task Force, has recently published an industry guidance document concerning programs to control Salmonella and help ensure the safety of low-moisture food products. Manufacturers that use a peanut-derived product as an ingredient in a food product may find GMA's document useful. FDA is not responsible for the content of GMA's document.

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FDA Warns Consumers About Potentially Contaminated Cheese
Mon, 09 Mar 2009 17:24:00 -0500

The U.S. Food and Drug Administration is warning consumers not to eat Queso Fresco Fresh Cheese Mexican style soft cheese (two specific lots) or any Queso Cotija Molido Mexican style grated cheese manufactured and distributed by Peregrina Cheese Corp. of New York City. These products could be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in pregnant women, young children, frail or elderly people, and others with weakened immune systems.

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FDA: Insulin Pens and Insulin Cartridges Must Not Be Shared
Thu, 19 Mar 2009 11:50:00 -0500

The U.S. Food and Drug Administration today issued an alert to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients due to the potential risk of transmitting blood-borne pathogens such as HIV and the hepatitis viruses.