Fibromyalgia Drug Savella is Dangerous, Consumer Group Says
Savella, the prescription drug approved last year to treat the mysterious pain disorder fibromyalgia, can lead to dangerously high blood pressure and should be pulled from the market, a leading U.S. consumer advocacy group said.
Public Citizen has sent a letter to the Food and Drug Administration asking for the agency to order the Forest Labs and Cypress Bioscience drug out of pharmacies, just one year after Savella was approved for treating fibromyalgia, according to an Associated Press report.
Patients with fibromyalgia commonly suffer from muscle soreness, headache, fatigue, depression, and other general pain-related symptoms. Millions of Americans have the disorder, which is not widely understood by the medical community. It is suspected that fibromyalgia is caused by abnormalities in how patients with the disorder process pain nerve signals.
Savella Rejected by European Drug Regulators
Last year, European drug regulators refused to approve Savella (known generically as milnacipran), citing a lack of data on its effectiveness and side effects. Public Citizen said the FDA should have done the same.
“FDA should never have approved Savella for fibromyalgia, and should now immediately undo its error by removing it from the market,” states the petition from Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, according to the AP.
Studies Raise Effectiveness, Safety Questions
Studies by the makers of Savella found about one in five patients taking the drug had hypertension (also called high blood pressure) compared with seven percent of those taking a placebo pill. Savella belongs to a class of antidepressants which have been linked to increased blood pressure.
The studies also showed Savella achieved only modest gains in pain relief among users. About nine percent of patients on Savella significantly reduced their pain, compared with seven percent of those taking placebo, Public Citizen said.
Physicians have written about 250,000 prescriptions for Savella since the drug was approved by the FDA in January 2009. The FDA has approved two other drugs for the treatment of fibromyalgia, including Eli Lilly’s antidepressant Cymbalta and Pfizer’s anti-seizure treatment Lyrica, the AP reports.
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