FDA urged to ban sales of fibromyalgia treatment.
The AP (1/21, Perrone) reports the consumer advocacy group Public Citizen has asked the Food and Drug Administration "to pull Savella off the market, almost exactly a year after it was cleared to treat fibromyalgia." Savella, which is co-marketed by Forest Laboratories Inc. and Cypress Bioscience Inc., came under scrutiny after "company studies of the drug showed 20 percent of patients taking Savella had hypertension, or high blood pressure." The FDA is said to have already cleared two other fibromyalgia treatments.
Dow Jones Newswire (1/21, Shwiff) reports Public Citizen said the drug had already been rejected by European regulators who found the benefits to be "marginal." Sidney Wolfe, director of Public Citizen's Health Research Group, said the drug posed "serious safety risks that outweigh the benefits," according to Bloomberg News (1/21, Thomas).
Sunday, January 24, 2010
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