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German pharmaceutical firm Bayer AG has been requested to withdraw Trasylol, a coagulant drug, from the market until more data becomes available regarding the drug's safety. One clinical study has indicated Trasylol could be linked to a 50% increased risk of death than rival medications. Trasylol had worldwide sales totaling $223.5 mil in 2006.

Swiss pharmaceutical firm Novartis AG received approval by the European Union to market a generic version of epoetin alfa, an anti-anemia drug, in Europe. The non-generic version, Eprex, is marketed in Europe by Johnson and Johnson.

U.K.-based pharmaceutical company GlaxoSmithKline PLC shares dropped by 7% after analysis by Cleveland Clinic cardiologist Steven Nissen suggested a potential cardiovascular risk in patients taking Glaxo's antidiabetic drug Avandia. Avandia sales totaled $3 bil in 2006.

Sanofi S.A. has obtained approval from the US Food and Drug Administration for its viral vaccine to prevent avian influenza in humans. The vaccine will not be marketed to the general public, but is expected to provide a measure of protection for workers who have a higher risk of contracting the disease.

At the request of the U.S. Food and Drug Administration, pharmaceutical companies are putting warning labels on their sleeping medications. Adverse effects include severe allergic reactions and unconscious behaviors like driving while asleep.

Pharmaceutical companies in the United Kingdom, Switzerland, Japan, and the United States are researching existing diabetes drugs to see if they can be used in diabetes prevention. The potential market for a diabetes prevention drug could be as high as $15 billion per year.

Watchdogs that work for Medicaid Programs, insurers and nonprofit organizations are studying the advertising of pharmaceutical companies, debunking advertising spin on new medications. By studying the clinical trials closely they are able to help the consumer understand what the research is really saying.

The U.S. system for drug approval and the Food and Drug Administration's procedures for responding to drug safety issues after drugs are approved is discussed in light of the recent recall of several high-profile medications in the United States. Drug approval and monitoring procedures in such countries as France, Britain, and Sweden are also examined.

Pfizer Inc.'s new antiarthritic drug, Celebrex has been recalled due to increased risks of cardiovascular problems. United States Food and Drug Administration faces the challenge of detecting and responding to long term adverse side effects that emerge after the agency has approved them.

The recent recall of Vioxx is highlighting concerns about how regulators deal with evidence of risks once a drug has been approved. There are also questions about whether the FDA is striking the proper balance between the potential benefits and risks of drugs.

Recent Food and Drug Administration analysis indicates that antidepressants increase the chances of suicide in young patients. The agency will likely recommend label changes and other regulatory improvements.