The North American Menopause Society held its annual meeting Oct. 9 to 12. An article posted a few days earlier stated that hot flashes would be “extensively discussed” at the meeting because “temperature control is such a preoccupation for menopause.” There would be 13 presentations on low-dose paroxetine mesylate (brand name Brisdelle), “the first nonhormonal treatment for hot flashes to be approved by the US Food and Drug Administration.” A link was provided to an article about the FDA approval.
The article is titled “Brisdelle okayed as first nonhormonal Rx for hot flashes.” However, the content of the article states: “The first nonhormonal drug for hot flashes associated with menopause was approved by the US Food and Drug Administration (FDA) today despite an agency advisory committee having rejected it as too much risk for minimal benefit. …The FDA’s Advisory Committee for Reproductive Health Drugs voted 10 to 4 against recommending approval. …The FDA is not obliged to follow the advice of its advisory committees, but …it usually does.”
With regard to risks, the same article states: “Critics said the drug’s minimal superiority to a placebo did not outweigh the risk for suicide ideation and osteoporosis, 2 adverse events associated with paroxetine. …The drug’s label features a boxed warning about the increased risk for suicidality. The label also warns clinicians that paroxetine mesylate can reduce the effectiveness of the breast cancer drug tamoxifen if taken together, increase the risk for bleeding, and comes with the risk for serotonin syndrome.”
Risks might be worth it if they are unlikely and there is a large benefit. In testing paroxetine did better than placebo, so it was accurate to state that the medication had an effect. However, the absolute advantage of the medication compared to placebo was small. For example, at week 4 of the study, 60% of the women taking the medication reported relief but so did 48% of the women taking a placebo; at 12 weeks, 47.5% vs. 36.3%.
Some clinicians with patients with severe hot flashes, and some women themselves, have had the experience that serotonin reuptake inhibitors (the class of drugs that includes Brisdelle) have worked. The article on the FDA approval speculates on why the medication was approved: “In a news release, the agency seemed to explain why it overrode the recommendation of its advisory committee when it came to paroxetine mesylate. ‘There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments,’ said Hylton Joffe, MD, director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research.”
For women with severe hot flashes, an effective treatment is needed. Yet, surely, a treatment with potential side effects should pass a high bar before being FDA approved.