FDA Approves Low Dose Paroxetine for Hot Flashes

Estrogen remains the gold standard which we have to offer women suffering from menopausal symptoms.  That's why the Women's Health Initiative was arranged to compared women 10 years post-menopause such that they were unable to tell if any decrease in menopausal symptoms was due to estrogen or placebo.  Fine but what about those women can't/shouldn't use Estrogen to control their menopausal symptoms?  Well, many physicians have been recommending off-label use of Paroxetine to control the hot flashes.

So perhaps it should come to some as relief that the FDA just approved a low 7.5mg dose version of Paroxetine, branded as Brisdelle, to be used to manage hot flashes.  After all, it's a relief that we have other options.  Yet, the Food & Drug Administration went against the strong recommendations of its Advisory Panel which did not find adequate proof of benefit (just one less hot flash per day).  Which raises the question, if you're going to ignore your Advisory Panel, why convene them in the first place?

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