US consumer group calls for withdrawal Forest/Cypress fibromyalgia drug Savella

The fibromyalgia drug Savella (milnacipran) should immediately be taken off the market because its dangers outweigh its benefits, Public Citizen said in a petition to the Food and Drug Administration. Manufactured by Cypress Bioscience and Forest Laboratories, Savella has been sold in the USA since May 2009.

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 USA, approximately 250,000 prescriptions have been filled, with doctors writing more prescriptions every month, says the consumer group.

In two randomized clinical trials, Savella 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% of those who took Savella developed hypertension, compared to 7.2% of those on a placebo.