Public Citizen is calling on the Food and Drug Administration (FDA) to pull the fibromyalgia drug Savella from the market immediately.
In its petition to the FDA, Public Citizen notes that the European Medicines Agency (EMEA), which regulates drugs on the Continent, rejected Savella'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 with 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. In fact, FDA warned last year of problems with Savella.
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.
Savella is manufactured by Cypress Bioscience Inc. and Forest Laboratories Inc., and has been sold in the U.S. since May 2009.
Savella is not the only treatment for fibromyalgia. The FDA approved another drug, Lyrica, in 2007.
