Summary

Original source:
http://www.chicagotribune.com/business/chi-0508170222aug17,1,4130754.story?coll=chi-business-hed

Details

• The Food and Drug Administration denied a consumer group's petition to take Abbott Laboratories' prescription weight-loss drug Meridia off the market, the company and consumer group confirmed Tuesday.
• "This decision is good news for obese patients and their physicians who are considering pharmacotherapy who may have been alarmed by Public Citizen," said Dr. John Leonard, Abbott's vice president of global medical affairs.
• The drug has been shown to elevate blood pressure in patients, something Abbott says is clearly spelled out on the FDA-approved label.
• Meridia returned to the spotlight last fall when FDA safety officer Dr. David Graham listed it among five potentially dangerous drugs the agency needed to review--a list that also included cholesterol drug Crestor, painkiller Bextra, acne drug Accutane and asthma medicine Serevent.
• Graham's blockbuster testimony last fall before a U.S. Senate panel--called after a study highlighted risks associated with the arthritis drug Vioxx--came as Congress first began to consider ways the FDA could improve its surveillance of drugs after they hit the market.
• While the FDA denied Public Citizen's petition, it has been working with Abbott to improve information highlighting appropriate use of the drug.
• Abbott and researchers in the medical community say they are happy the FDA supported Meridia, given the high levels of obesity in the United States and the few available treatments.
• "This means the FDA has made another mistake," said Dr. Sidney Wolfe, director of Public Citizen's health research group.
• Meridia, which Abbott acquired in a 2001 merger, is most often criticized for promoting limited weight loss in exchange for increased risk of high blood pressure, especially in the obese patients who are likely candidates of the drug.
• Graham said the FDA should consider whether the drug's benefits outweigh the risks of high blood pressure and stroke, indicating patients didn't stay on the drug because of such risks.

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