FDA Panel Says No To Non Hormonal Drugs for Hot Flashes

Women who suffer from hot flashes but cannot take hormones, the most effective remedy for vasomotor symptoms, had their hopes for relief dashed when a FDA advisory committee yesterday voted against approval of what would have been the first non hormonal drugs for hot flashes in menopausal women. Under consideration were:

Gabapentin - A recent clinical trial showed that an extended release version of this drug improved sleep and reduced hot flashes in menopausal women. But the panel was “unimpressed by the drug’s limited efficacy in controlling hot flashes in light of its adverse cognition and other central nervous system effects.”

Paroxetine Mesylate – (an SSRI antidepressant)- though this drug is already being used “off label” to treat hot flashes and many physicians think a low dose would offer a beneficial effect, the panel was concerned about the relatively small benefit compared to placebo as well as the drug’s safety profile, particularly its association with suicidal thoughts and osteoporosis.

Dr. Marjorie Gass, executive director of the North American Menopause Society (NAMS), was one of several medical professionals who testified yesterday before the panel about the need for non hormonal options for moderate to severe hot flashes;

“Although hormone therapy (HT) provides a safe and effective option for many women, it is not the right choice for all women, because of health histories such as breast cancer or previous blood clots and, oftentimes, an unfounded fear regarding the risks of hormones,” said Dr. Gass.

As many as 40 percent of women may experience hot flashes for more than seven years and as many as 15 percent for more than 15 years. These discouraging statistics mean that many women may need help for their hot flashes for longer than most studies judge hormone therapy to be safe to use.

Though the panel voted thumbs down on these two drugs, we haven’t heard the last word on this. The FDA is expected to make a final decision on gabapentin by May 31 and paroxetine mesylate by June 28th. The agency doesn’t have to follow the advice of its advisory committees, but it usually does.