FDA Begins Quarterly Drug Safety Reports

The U.S. Food and Drug Administration (FDA) has begun publishing quarterly reports on its website (http://www.fda.gov) that identify drug products that are under safety investigation by the agency, and the specific health risks associated with use of the drugs.

On Thursday, the FDA released Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) January - March 2008. The FDA is providing this information to consumers and health care providers under the 2007 Food and Drug Administration Amendments Act, which requires the agency to release public quarterly updates of new safety information or potential signals of serious risk associated with certain drugs. In a News Release announcing the new reporting program, the FDA stressed that "the appearance of a drug on [the] list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk." Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research has this advice for patients: "Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently."

WebMD reports that the FDA's Adverse Event Reporting System (AERS) "collects reports from patients, hospitals, doctors, and drug companies about suspicious problems that might -- or might not -- be related to a medication."

• Read the FDA's First Quarterly Drug Safety Report (January - March 2008)
• FDA News Release on the New Reporting System
• More Information on the FDA's New Reporting System (FDA)
• WebMD: 20 Drugs the FDA is Watching
• Reuters: FDA Lists Drugs Under Safety Probes
• Taking Prescription Medications: Things You Should Know (FindLaw)
• Pharmaceutical Drug Liability (FindLaw)