Public Citizen Files a Petition to Remove Fibromyalgia Drug from the Market

Last week, the non-profit, consumer advocacy group known as Public Citizen filed a petition to the FDA on the removal of Savella (milnacipran), a selective serotonin and norepinephrine dual reuptake inhibitor (SNRI) used to treat fibromyalgia, from the market. Savella was approved last year, but Public Citizen representatives say that the drug "can lead to dangerously high blood pressure." With more than 250,000 prescriptions written since its approval, they claim that the FDA should not have approved the drug for the same reasons that the European Medicines Agency did not approve it: lack of effecacy data and its side effects.

This call occurred after the results of two clinical trials were reviewed and found that milnacipran increased "blood pressure, heart rate and suicidal thoughts," according to the petition. In the Food and Drug Administration: Clinical Pharmacology Review, it states that all patients treated with milnacipran "had higher blood pressure and heart rate than placebo at all doses." In fact, Bob A. Rappaport, MD, director, Division of Anesthesia, Analgesia, and Rheumatology Products, said that "although the dominant symptom of fibromyalgia is pain, the drug did not relieve patients' pain in the clinical trials."

Have you written prescriptions for Savella? Do you think a petition needed to be filed with the FDA to remove the drug?