Wednesday, November 16, 2011

F.D.A. Is Urged to Issue More Alerts About Drug Risks - NYTimes.com

by Bruce Japsen

"The process of posting potential safety signals began in the first quarter of 2008 as a result of legislation signed into law the previous year by President George W. Bush. The law, known as the Food and Drug Administration Amendments Act, directed the agency to conduct regular screenings of its adverse event reporting database and post quarterly reports online. The legislation was passed in the wake of several high-profile drug scandals, including the increased risks of heart attacks among those taking Vioxx, the painkiller that ultimately was withdrawn from the market.

Dr. Sidney Wolfe. director of health research at the Washington nonprofit group Public Citizen who also sits on a drug safety advisory committee to the F.D.A., said: “For most, if not all, of these drugs, alternative (usually older) drugs with comparable efficacy and more established safety records can be found.”

F.D.A. Is Urged to Issue More Alerts About Drug Risks - NYTimes.com:

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