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%.