The FDA has just approved an old antidepressant called paroxetine to ease symptoms of menopause. Although this medication was originally prescribed for depression under the brand name Paxil, it will now be offered in a lower dose as the brand name Brisdelle.
It is being marketed as the first non-hormonal treatment for hot flashes. This should be welcome, as many women are being discouraged from relying on estrogen or estrogen and progestin. Research shows that although such hormone replacement therapies (HRT) are helpful against hot flashes, they increase the risk for cardiovascular problems and breast cancer. Unfortunately, Brisdelle carries many questions of its own.
The FDA approval process was controversial because an advisory committee of outside experts voted 10 to 4 against approval on the grounds that the overall risk benefit profile was not favorable. The problem is that paroxetine can cause side effects such as headache, fatigue, nausea, vomiting, abnormal bleeding, impaired judgment or suicidal thoughts. Stopping suddenly may trigger withdrawal symptoms including nightmares, muscle cramps, anxiety, headache, fatigue and insomnia.
There is new research from Japan suggesting that the botanical medicine Pycnogenol, from the bark of the French maritime pine, may help alleviate hot flashes. The protocol used 30 mg of Pycnogenol or placebo twice daily for three months, and the women getting Pycnogenol fared much better than those on placebo (Journal of Reproductive Medicine, Feb. 2013). For information on other non-drug approaches to alleviating uncomfortable symptoms, we offer our Guide to Menopause.