What are the nonhormonal treatments for the symptoms of menopause?

Updated: Jun 06, 2018
  • Author: PonJola Coney, MD; Chief Editor: Richard Scott Lucidi, MD, FACOG  more...
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Answer

Answer

In June 2013, the FDA approved paroxetine mesylate (Brisdelle) as the first nonhormonal therapy for vasomotor symptoms (VMS) (hot flashes) associated with menopause. [7, 8]

Despite the FDA's Advisory Committee for Reproductive Health Drugs vote against recommending approval (noting that paroxetine’s minimal superiority to a placebo did not outweigh the increased risks of suicidal ideation and osteoporosis), approval was based on 2 clinical trials involving 1,175 postmenopausal women with moderate to severe hot flashes. [7, 8, 108]

Results of both studies showed paroxetine 7.5 mg reduced the frequency of VMS significantly more than placebo. [108] However, labeling for paroxetine will include a boxed warning about the increased risk for suicidality and a warning that paroxetine mesylate can reduce the effectiveness of the breast cancer drug tamoxifen, increase bleeding risk, and increase the risk for serotonin syndrome. [7, 8]

Antidepressants and gabapentin have been widely used off-label for VMS.


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