A consumer advocacy group has asked the Food & Drug Administration (FDA) to ban Savella, a drug approved to treat fibromyalgia. Public Citizen’s petition says the risks of Savella outweigh its benefits.
According to the Public Citizen petition, in two randomized clinical trials, Savella was found to increase blood pressure, heart rate and suicidal thoughts. 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.
Public Citizen also said neither of Savella’s trials showed any statistical effectiveness in treating fibromyalgia 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.
In July 2009 – just month after the FDA aproved it, the European Medicines Agency rejected Savella’s approval for fibromyalgia, stating that its benefits were “marginal” and “did not outweigh its risks.”
