Hot flash remedy OKd by FDA, flouting its own panel

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Menopause in Action

It is estimated that over 20 million American women suffer from moderate-to-severe peri-menopausal hot flashes, and that most of its sufferers are not treating them. Some of that non-treatment stems from the federal WHI study of 2002 which seemed to show several serious risks from the most effective form of menopausal symptom treatment, hormone replacement therapy (HRT).

Now a new, non-hormonal treatment for menopausal hot flashes has been approved by the FDA: Brisdelle, whose active ingredient is a low-dose of paroxitene, an SSRI-type of antidepressant. As used in Paxil, GSK s antidepressant, there are from 20 to 50 mg of paroxitene in a daily dose. The newly-approved drug has 7.5 mg. The drug company s two studies showed a reduction in hot flashes among the treated women from about 8 episodes daily down to about 2 per day.

The FDA panel reviewing the application last March voted 10-4 against it, expressing concern about the boxed warning of suicidality mandated on all SSRIs, as well as the minimal improvement from the drug as compared to the placebo group, which also noted a reduction in hot flashes of about 4 per day.

There are a variety of FDA-approved treatments for hot flashes, but all contain either estrogen alone or estrogen plus a progestin: HRT.

Hot flashes associated with menopause occur in up to 75 percent of women and can persist for up to five years, or even longer in some women. Hot flashes are not life-threatening, but the symptoms can be very bothersome, causing discomfort, embarrassment and disruption of sleep.

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 V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive and Urologic Products in the FDA s Center for Drug Evaluation and Research. Today s approval provides women with the first FDA-approved, non-hormonal therapeutic option to help ease the hot flashes that are so common in menopause.

ACSH s Dr. Ross had this to say: While I m pleasantly surprised that CDER's Dr. Joffe had the courage to overrule the advisory panel and approve this low-dose paroxitene formulation, the whole process illustrates several examples of why our drug evaluation and approval process is so dysfunctional. Going back to the 2002 WHI metanalysis, the data mining that occurred was so obvious and the conclusions reached from it were so counter to sound science, it s just too bad it s still talked about at all. And it has chilled a good segment of the population that might benefit from HRT, specifically women with frequent disabling hot flashes. More recently, the FDA panel was spooked by the absurd suicidality warning and recoiled from approving even this low-dose version of an effective SSRI. Maybe they should petition the FDA to pull Paxil from the market, since it has a much higher dose of the drug they seem to fear.