Seventy five percent of women who become menopausal will have hot flashes, night sweats and sleep problems which, although not life-threatening, can certainly impact quality of life. I have spent much of my career writing about this and indeed treating women with these symptoms. For those who have no contraindications, hormone therapy will usually be the “cure” they seek (as well as maintain bone density, vaginal integrity, skin collagen, perhaps impact cognition and focus, and at least initially, help prevent atherosclerosis and decrease abdominal fat distribution). There is, however, concern about the impact of oral estrogen and synthetic progestin on the risk of blood clots, breast cancer and even dementia. There are new ways to prescribe estrogen that maybe safer (transdermal) and alternatives to synthetic progestin. But a considerable number of women have clear contraindications and/or choose not to take hormone therapy. There is also a valid concern about long-term use; after three to five years of successful hormone therapy the question remains, “Is it safe to continue?” Some women will stop and have minimal symptoms but others will return to the same hot, bothered and sleepless condition that caused them to go on hormones in the first place! Until now, there been no FDA approved non hormonal medications to help treat these vasomotor symptoms.
So although I knew about this medication and have already started to prescribe it for appropriate patients, I wanted to mention the new article that was published in the May 8 issue of the New England Journal of Medicine, “FDA Approval of Paroxetine for Menopausal Hot Flashes” Paroxetine is also known as Paxil which is generally prescribed in doses of 10, 20 and up to 40 mg for several psychiatric conditions, including major depressive disorder. And as you may have noted as you watch or read the myriad direct to consumer ads, this type of antidepressant (as well as most others) has warnings about monitoring patients for suicidal thoughts and behaviors and the directive to discontinue treatment if there’s worsening depression or suicidality. The new medication, called Brisdelle contains a much much lower dose of Paroxetine, only 7.5 mg. It is a very mild selective serotonin reuptake inhibitor that causes a mild increase in that “feel good brain hormone”, serotonin.
The history of the FDA approval is interesting and was the subject of the article. The approval ran counter to the recommendation of the FDA reproductive health drugs advisory committee which had concluded, by a vote of 10 to 4 , that the overall benefit-risk profile of Brisdelle did not support approval. The FDA always carefully considers the advice from its advisory committees but it is not required to follow their recommendations… Here is what the committee considered: Among a total 1184 menopausal women who had a median of 10 moderate-to-severe hot flashes per day, Brisdelle was shown to provide modest relief in comparison to placebo. At week 12 (in one of the studies) there was a median reduction from baseline of 5.9 moderate-to-severe hot flashes per day with Brisdelle as compared with the median reduction of 5.0 per day with placebo. At week 12 (In a second study), there was a median reduction from baseline of 5.6 moderate-to-severe hot flashes per day with Brisdelle as compared with the median reduction of 3.9 per day with placebo. But even though this was a very modest effect, Brisdelle remained efficacious at six months, the latest time point assessed. Because of Brisdelle’s very modest efficacy and concerns about suicidal ideation the advisory committee’s 10 to 4 vote against approval occurred. But recognizing that no hormone-free drug product has been approved to treat vasomotor symptoms, the FDA concluded that Brisdelle still offers a clinically meaningful benefit for some menopausal women.
So yes, we have a new FDA approved medication for hot flashes and in many cases insurance will pay for it. I applaud the fact that we have this alternative; I’m not sure that it will work for every woman but for those of my patients who cannot take hormones and who have quality-of life-affecting symptoms, it’s worth a try.