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Group Calls For Fibromyalgia Drug Savella Recall

The Food & Drug Administration has approve the drug Savella as a safe and effective drug to treat fibromyalgia, and doctors have written 250,000 prescriptions for the drug in the last year – but is Savella safe? Respected consumer advocacy group Public Citizen has publicly asked the FDA to recall the drug based on evidence that it causes hypertension and could increase the chances of suicide. The group also puts forth that the drug has not properly been shown to reduce the symptoms of fibromyalgia.

Fibromyalgia is an elusive and mysterious ailment that causes generalized pain, depression, muscle soreness, headaches, and fatigue. Little is known about the causes or treatments for the disease, and yet three antidepressive pain medications, including Savella, have been approved to treat the illness. However, the Public citizen says that tests show that the drug can lead to dangerously high blood pressure and, like other antidepressants, can be linked with suicide.

In addition, the consumer group complains that the clinical trials proving the medication’s efficacy on patients with fibromyalgia had unimpressive results – and were shortened in order to show that just nine percent of patients said that it relieved symptoms. Seven percent of those taking a dummy pill said that the medication relieved symptoms.

Savella, also known as milnacipran, is manufactured by Cypress Bioscience, Inc. and Forest Laboratories, Inc. The European Medicines Agency (EMEA) did not approve Savella for fibromyalgia treatment, saying that the risks greatly outweighed the benefits. Fibromyalgia is said to affect 2 to 4 percent of the population, though some doctors believe it is over diagnosed – or not a true disease at all.

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