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Petition Fda To Ban Fibromyalgia Drug


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#1 vivolenta

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Inviato 05 febbraio 2010 - 12:54:47

http://sacfs.asn.au/...etition_fda.htm


The fibromyalgia drug Savella should immediately be taken off the market because its dangers outweigh its benefits, Public Citizen said today in a petition to the Food and Drug Administration (FDA). The European regulatory authority, the European Medicines Agency (EMEA), rejected the drug’s approval for fibromyalgia in July 2009, stating that its benefits were “marginal” and “did not outweigh its risks.” This was shortly after the FDA approved the drug in January 2009.

Since the drug went on the market in the U.S., approximately 250,000 prescriptions have been filled, with doctors writing more prescriptions every month.

In two randomized clinical trials, Savella, also known by its generic name milnacipran, was found to increase blood pressure, heart rate and suicidal thoughts, Public Citizen’s petition said.

Among patients who had normal blood pressure at the beginning of the study, 19.5 percent of those who took Savella developed hypertension [high blood pressure], compared to 7.2 percent of those on a placebo.

“Because Savella is a drug that produces only a marginal effect on pain, the main problem for which patients seek treatment, and has the potential to be quite dangerous, it is clear that it should not be sold,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.
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