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Nonhormonal Drugs for Menopausal Symptoms Nixed by FDA

by Dr. Barb DePree

So much for WISHes.

Following the approval of Osphena, a nonhormonal drug for vaginal pain, or dyspareunia, an advisory panel for the Food and Drug Administration (FDA) just voted against approving two nonhormonal drugs for the treatment of hot flashes.

Hot flashes, night sweats, and the sleep disturbance that accompanies them affect about 75 percent of perimenopausal women. Often, they are merely inconvenient, but for some women, they are severe enough to affect sleep, sex, and overall well-being. And they may continue for years—long after menopause is over.

However, based on the results of several rounds of clinical trials for gabapentin, a drug already used to treat seizures and nerve damage from shingles, and other trials for paroxetine, an antidepressant (the active ingredient in Paxil), the FDA panel voted overwhelmingly to deny approval.

The panel’s objection to both drugs was that their effectiveness didn’t outweigh the risks and side effects associated with their use. The most common side effects of gabapentine are dizziness and drowsiness. The most common side effects of paroxetine are nausea, sweating, drowsiness, and headache.

According to a recent New York Times article, women in the gabapentine trial experienced an average of 11 hot flashes a day. At the end of 12 weeks, they were down to about 4 per day. But the women on placebos saw almost as much relief—their hot flashes had dropped to about 5 per day. Thus, “women taking placebos in the trials experienced a substantial reduction in hot flashes that the drugs could not beat in any pronounced way.”

Women in the paroxetine trial fared slightly better, but the FDA panel decided that it still hadn’t cleared the bar for approval.

Voices on both sides of the debate are intense.

“They don’t work and cause dangerous side effects,” the consumer advocacy group Public Citizen testified before the FDA panel.

On the other hand, Linda Keyes, one of the panel members who voted to approve the drugs, said that the need for nonhormonal treatment “is high enough that I feel that a very modest reduction [in hot flashes] is still acceptable, assuming the risks are known and carefully watched, which I believe they can be,” according to an article on WebMD.

Obviously, these results are disappointing for women who are looking for a safe, federally approved, nonhormonal treatment for hot flashes and sleep disturbance. Currently, the go-to treatment for these menopausal symptoms is hormone therapy, and many women either can’t take hormones or choose not to because of the risk of stroke and breast cancer.

Both gabapentine and paroxetine are available off-label, and doctors have been prescribing them for menopausal symptoms for years. They, and other off-label options, can still be considered for treatment of menopausal symptoms—yet another reason for a detailed discussion with your health care provider so you’re making the best—and best informed—choices for you.


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