FDA approves an antidepressant for hot flashes
Is it hot in here, or am I just depressed?
For many menopausal women, hot flashes are just depressing. And depression, which affects at least one in four women ages 40 to 59, can intensify the misery of hot flashes, as well. No surprise, then, that a pharmaceutical company came up with the idea to market an antidepressant for treatment of vasomotor symptoms, a.k.a. hot flashes.
And on Friday, bucking the recommendation of its advisory committee on reproductive health drugs, the Food & Drug Administration approved the idea. The agency gave its blessing to Noven, a subsidiary of the Japanese pharmaceutical company Hisamitsu, to market Brisdelle, a low-dose version of the antidepressant paroxetine, known commercially as Paxil, for women with moderate to severe hot flashes.
Brisdelle is the first nonhormonal treatment for the hot flashes of menopause approved by the FDA. In clinical trials presented to the FDA, the 7.5-milligram dose of paroxetine (far less than the 30-to-40-milligram dose widely used to treat depression) reduced the frequency of hot flashes in women who had seven or more a day by 57% to 59%.
That’s not as effective as the reduction seen by women who take hormone replacement therapy, reportedly 65% to 80%. But for women plagued by hot flashes yet concerned about the increased risk of heart disease, stroke, blood clots and breast cancer associated with HRT use, a low-dose antidepressant may be a good alternative.
In March, the FDA’s advisory committee on reproductive drugs found low-dose paroxetine’s level of effectiveness in reducing hot flashes underwhelming, and voted to recommend against approval. Women taking a placebo medication reported a 40% to 48% reduction in hot flashes, so the panel was skeptical that the further reduction reported by women taking paroxetine was “clinically meaningful.”
The same committee also recommended against approval of an antiseizure drug, gabapentin (known commercially as Neurontin) for hot flashes.
As a selective serotonin reuptake inhibitor (SSRI), Brisdelle may have side effects that are already problematic for menopausal women, including reduced sex drive and a potentially elevated risk of osteoporotic fractures. In its proposal to the FDA, Noven said it was prepared to conduct a post-marketing study to assess bone safety in women taking Brisdelle.