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."

Fibromyalgia is thought to result from neurological changes in the perception of pain, specifically a heightened sensitivity to stimuli that for most people would not normally be painful. Lyrica binds to a specific protein in these overexcited nerve cells and works to soothe damaged nerves. This is thought to reduce pain in patients living with fibromyalgia, although the exact mechanism of how Lyrica acts in fibromyalgia is not known.

Lyrica is not a completely new drug. It was developed in January of 2005 by Pfizer to treat the peripheral neuropathetic pain often suffered by diabetic patients. But after a number of studies, it was found that the medication showed some benefit for fibromyalgia, and it has been prescribed "off label" ever since.

While many patients enjoyed a reduction in their pain, improvements in their sleep and energy levels, some disagreed. Dizziness and daytime drowsiness were the most commonly mentioned side effects. For some, these side effects dissipated over time, but for some, they were too disruptive to continue taking the medication. Some studies, according to Fibromyalgia Network, also showed that for some, lower doses improved sleep but higher doses were needed for pain control.

"I had to give up my career and I wasn't able to participate in a lot of my children's activities," said Carolyn Bishop, a fibromyalgia patient and participant in one of the Lyrica clinical trials, as reported by Pfizer. But since she started taking Lyrica, she's "had less pain and felt better."

"I had to give up my career and I wasn't able to participate in a lot of my children's activities," said Carolyn Bishop, a fibromyalgia patient and participant in one of the Lyrica clinical trials. But since she started taking Lyrica, she's "had less pain and felt better."