FDA Recall Attorneys

Dangerous Drugs Update

Zocor Rhabdomyolysis Warning
March 19, 2010 - During the ongoing review of the risks of statin drugs, the FDA have issued a warning for Zocor. The warning cites Zocor's increased risk of causing muscle injury, rhabdomyolysis, and potentially fatal kidney damage in patients when taken in its highest available dose.

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Yaz and Yasmin Ad Warnings
March, 2010 - Bayer Healthcare Pharmaceuticals has recently released new advertisements for their birth control pill, Yaz. These new ads come even as lawsuits continue to mount against Bayer for serious health conditions believed to have been caused by Yaz and Yasmin. The FDA has previously issued warnings to the Yaz and Yasmin manufacturer when marketing campaigns for their dangerous birth control pills have included information that is confusing for consumers.

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About the FDA

The Food and Drug Administration (FDA) is a part of the Department of Health and Human Services, tasked with overseeing the safety of foods and drugs in the American market. In addition to foods and drugs, the agency is responsible for testing cosmetics, biological products and medical devices. It also tests radiation-emitting consumer products, such as televisions and cell phones. The FDA promotes food and drug safety through a system of advisory committees, inspections, adverse drug event reports and food or drug recalls.

FDA Offices

The FDA has nine offices, each delegated with specific goals regarding America's food supply. The Office of Regulatory Affairs and the Office of the Commissioner oversee inspections and administration of the department respectively. The remaining seven offices directly watch and direct the sale of food, cosmetics and drugs in the United States

• Center for Drug Evaluation and Research: This office analyzes prescription and over the counter (OTC) drugs and medical devices, uncovering deceptive or misleading drug promotional claims in media advertising.
• Center for Biologics Evaluation and Research: This office reviews more complex bio-molecular drugs and therapies for safety and effectiveness. Representative concerns: vaccines, gene therapy, blood products and similar bio-molecular drugs or procedures.
• Center for Food Safety and Applied Nutrition: This department is responsible for the safety of most food products, excepting meat, poultry and eggs.
• Center for Veterinary Medicine: Monitors the health and productivity of food animals and approves drugs administered to food animals.
• National Center for Toxicological Research: Researches food and drug safety.
• Office of Chief Counsel: This branch of the FDA initiates legal actions against those suspected of violating US food and drug laws. Often works in concert with the Customs Department and other government offices.
• Office of Regulatory Affairs: This office is responsible for inspecting and analyzing foods in the US market, including foods imported from other countries.

In addition to these offices, two FDA-affiliated organizations are involved in the monitoring of America's food supply.

• Joint Institute for Food Safety and Applied Nutrition: Provides the research infrastructure to food safety programs.
• National Center for Food Safety and Technology: This Illinois-based center promotes joint industry and FDA research on subjects of food safety and technology research.

Limits of the FDA

A few food and drug items do not fall under FDA jurisdiction. The FDA does not:

• Regulate alcohol or illegal drugs
• Regulate farmed meat and poultry (beef, pork, chicken, etc.)
• Regulate drinking water, but does regulate bottled water

The FDA advances public health by speeding the approval of new devices or processes that make foods and medicines more effective, safer and more affordable. The agency also provides the public with factual, science-oriented information on medicines and foods. With its power to issue warnings and enforce defective product recalls, the FDA is the watchdog of public health for the American people for food, drugs, biological products, medical devices and products emitting radiation.

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