FDA Panel Advises Against Two New Drugs for Hot Flashes

Advisers to the FDA on Monday voted decisively against approving two non-hormonal medications to treat hot flashes, a common symptom of menopause. By a vote of 12 to 2, the panel recommended against approving an extended-release form gabapentin. They voted down a low-dose version of paroxetine 10 to 4.

Although both drugs are FDA approved to treat other conditions-gabapentin for epilepsy and post herpetic neuralgia; paroxetine for depression-committee members said that the treatments offered only “marginal benefit” in the treatment of hot flashes. In a clinical trial of Depomed’s gabapentin, the reduction in the number of hot flashes in women taking gabapentin was not significantly significant when compared with women taking a placebo. Clinical trials of Noven’s paroxetine showed a statistically significant reduction in the number of hot flashes per day-a difference of .9 per day in one study and 1.7 per day in another-but advisers said the difference would not be clinically significant to women.

Critics of the decision argue that many women cannot or will not use hormonal treatments to manage symptoms of menopause, and non-hormonal options are desperately needed. They also note that, because of a lack of approved options, many are turning to unregulated treatments such as herbal supplements without medical oversight.