* The antidepressant paroxetine (under the trade name Brisdelle) has been approved to treat menopausal hot flashes.
* The dosage for this indication is lower than that used for psychiatric indications.
* Like all antidepressants, paroxetine carries the risk of increased suicidal ideation.
Paroxetine has become the first nonhormonal drug approved to treat hot flashes during menopause; it will be marketed for this indication under the trade name Brisdelle. Paroxetine is a selective serotonin reuptake inhibitor (SSRI), and at higher doses it is the active ingredient in the antidepressants Paxil and Pexeva. Like all SSRI antidepressants, paroxetine carries a boxed warning that it increases the risk of suicidal ideation. Exactly how paroxetine controls hot flashes during menopause isn't known. Although paroxetine's ability to do so was statistically greater than that of a placebo, its effect wasn't very different from the placebo's in minimizing hot flashes, and it decreased the number of occurrences by fewer than two events per day in most women.
The reason the Food and Drug Administration (FDA) decided to approve paroxetine for this new use is unclear, given that its Reproductive Health Drugs Advisory Committee had recommended denying approval at its meeting on the subject on March 4, 2013. A review of the minutes of the meeting reveals several factors that contributed to the recommendation to deny approval.
Because the difference between the placebo and the drug was so minimal (despite being statistically significant), the committee was evenly split in its vote on whether paroxetine was helpful in treating hot flashes from menopause. The committee strongly believed that, despite the statistical significance of the difference in effect, the difference wasn't clinically significant; the vote was overwhelmingly against paroxetine's clinical usefulness (10 votes no versus four votes yes). One of the concerns the committee had was that only one of the two clinical trials submitted by the applicants as evidence had a prespecified analysis of clinical efficacy. In that trial, a positive effect was seen at week 4 but not at week 12. The advisory committee's vote on approval leaned heavily away from it (10 votes no versus four votes yes).
The committee had considered a different drug, gabapentin (an antiseizure drug), earlier in the day for approval in treating hot flashes, and gabapentin had received a similar lack of support from the panel. The committee stated resoundingly, in a 12 to two vote, that it did not believe the drug's risk–benefit profile supported approval for hot flashes.
Following the committee's recommendation, the FDA didn't approve gabapentin for use as a nonhormonal treatment for hot flashes. It remains unclear exactly what criteria the FDA used to determine that paroxetine should be approved but gabapentin denied. However, from statements made by FDA officials at the advisory committee meeting, it does appear that the FDA was very interested in finding a nonhormonal treatment for menopausal hot flashes; there is indeed a need for such a treatment.
Nurses providing information about this therapy to women with moderate-to-severe menopausal hot flashes should emphasize that paroxetine may be helpful only to some women. Education of patients and their families should include the risk of suicidal ideation, and they should be instructed to contact the prescriber if any changes in mood or affect are noted while the patient is undergoing paroxetine therapy.
The FDA news release regarding the approval can be found at http://1.usa.gov/17pUcmn.