Posted: Jan 20, 2010 9:27 AM by Associated Press
A consumer advocacy group is asking government regulators to recall a drug they approved last year for a little-understood pain ailment, saying the pill can lead to dangerously high blood pressure.
A letter Wednesday from Public Citizen calls on the Food and Drug Administration to pull Savella off the market, almost exactly a year after it was cleared to treat fibromylagia. The drug is co-marketed by Forest Laboratories Inc. and Cypress Bioscience Inc.
Fibromyalgia is characterized by a wide range of pain-related symptoms, including muscle soreness, headache, fatigue and depression. Last summer European regulators rejected the drug due to lack of effectiveness data and side effects. Public Citizen argues the FDA should have reached the same conclusion.