1st U.S. Drug Approved for Fibromyalgia

Important Update:

December, 2019 – FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)
When used with CNS depressants, opioids, or in patients with lung problems.

Listen to the Podcast about this warning on the FDA site.

21 June 2007—(U.S. Food and Drug Administration press release) (.pdf) – Lyrica (pregabalin) has been approved by the U.S. Food and Drug Administration to treat fibromyalgia. It's the first drug approved in the United States to treat the condition that affects up to 6 million Americans, the agency said Thursday. People with fibromyalgia usually have chronic pain, muscle stiffness, fatigue, and sleep problems. The disorder affects more women than men, and commonly develops in early-to-middle adulthood. In the absence of a diagnostic test, doctors typically conduct physical examinations, evaluate symptoms, and rule out other possibilities, the FDA said.


Fibromyalgia Syndrome (Muscle Pain)