FDA Approves First Drug for Treating Fibromyalgia

On June 21, the Food and Drug Administration approved Lyrica (generic name: pregabalin) as the first drug to treat fibromyalgia, according to Pfizer.

This is a milestone, because prior to this FDA approval, those living with fibromyalgia (approximately six million in this country alone) had been forced to "make do" with drugs not officially approved for the symptoms of fibromyalgia. Medications were prescribed "off label" to treat the pain, fatigue, insomnia, headaches and digestive problems that are the hallmarks of the disease. Patients and their health care providers complained of needing to take multiple medications, and having problems with what their health insurance companies would cover. For instance, two of the most basic types of medications prescribed for fibromyalgia - anti-depressants and sleep aids - are classified by some HMOs as "mental health related" which not only perpetuates a long-fought-against stigma that fibromyalgia is "all in one's head." And in some cases, the HMO refuses to cover medications in these categories.

While Lyrica may not treat every symptom of fibromyalgia, it has been shown to help the major ones, and it also lends stronger credibility to the medical and health insurance communities that the disease is real and should be treated as such.

"This is an important day for people with fibromyalgia and a real opportunity to help physicians effectively manage this disorder," said Dr. Don Goldenberg, M.D., co-chair of the fibromyalgia guideline panel for the American Pain Society and professor of medicine, Tufts University. "Having a medication approved for use in fibromyalgia, along with research advances, will go a long way to improving our understanding and treatment of this common disorder."