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Savella Not Safe or Effective, Should be Banned, Group Says

Jan 22, 2010 | Parker Waichman LLP

The benefits of the fibromyalgia drug Savella do not outweigh its risks, according to the consumer advocacy group, Public Citizen. The group has petitioned the U.S. Food & Drug Administration (FDA) to ban Savella from the U.S. Market.

Savella was approved by the FDA in January 2009 as a treatment for fibromyalgia. 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, the European Medicines Agency rejected Savella’s approval for fibromyalgia, stating that its benefits were “marginal” and “did not outweigh its risks.”

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. 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.

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.

“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, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a press release announcing the group’s petition.

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