Forest - Savella: not worth the risk say Public Citizen

Public Citizen Petition to FDA: Dangerous Fibromyalgia Drug Should Be Pulled From the Market

Medication Has Limited Efficacy, Risky Effects

WASHINGTON, D.C. – 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, 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. “The FDA never should have approved Savella for fibromyalgia and should now immediately order the drug company to remove it from the market before large numbers of people suffer serious harm,” Wolfe said.

Based on the extent of increased blood pressure caused by Savella, the FDA medical officer who reviewed the drug estimated that persistent blood pressure hikes could increase the risk of a cardiovascular event (including death, myocardial infarction and stroke) by up to 50 percent.

Savella also puts patients at risk for other disorders, including seizures, addiction, excessive bleeding, mood disorders, fractures, glaucoma and gastrointestinal effects such as nausea and vomiting. In pregnant women, the drug also can lead to hazards for fetuses, newborns and nursing infants. Additional risks for men include testicular pain and problems with ejaculation.

The director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products stated that although the dominant symptom of fibromyalgia is pain, the drug did not relieve patients’ pain in the clinical trials.

Fibromyalgia is a chronic disease, but neither of the drug’s trials showed any statistical effectiveness beyond three months. And even within the trials’ three-month duration, more than 90 percent of users in the trial received no benefit from the drug at all.

Although not marketed as an antidepressant in the U.S., Savella is sold in Europe and Japan as such. The drug is required in the U.S. to have the “black box” warning for antidepressants, which points out an increased risk of suicide in children, adolescents and young adults. Manufactured by Cypress Bioscience Inc. and Forest Laboratories Inc., Savella has been sold in the U.S. since May 2009.

READ the petition.