FDA should not approve paroxetine or gabapentin for hot flashes, says Public Citizen

A drug approved to treat depression and other mental health disorders and another designed to prevent seizures and treat postherpetic neuralgia (a painful condition due to nerve injury following a shingles infection) should not be approved to relieve hot flashes because they don’t work and cause dangerous side effects, consumer advocacy group Public Citizen has told the US Food and Drug Administration.

Testifying before the FDA’s Advisory Committee on Reproductive Health Drugs, Michael Carome, deputy director of Public Citizen’s Health Research Group, urged the FDA not to approve the anti-depressant paroxetine and the anti-seizure/neuropathic pain medication gabapentin to treat vasomotor symptoms – hot flashes and flushing caused by menopause. In fact, the advisory panel voted against approval of both drugs, paroxetine from Hisamitsu and gabapentin (trade name Sefelsa) from Depomed (The Pharma Letter March 5).

Many well documented risks with the drugs