Advisory Panel Rejects Non-Hormonal Drug Therapy for Hot Flashes

Lisa Larkin MDContributed by Lisa Larkin, MD, FACP, NCMP

The future does not appear bright for menopausal women seeking non-hormonal drug therapies to treat moderate to severe hot flashes. Last week, an FDA advisory panel overwhelmingly rejected the use of gabapentin (an anti-seizure medication) and paroxetine (an anti-depressant medication), both of which have been successfully used “off label” by doctors to treat menopausal women suffering with hot flashes.

Why did the advisory panel reject the non-hormonal drug therapy?

The panel felt the drugs didn’t do enough to control the severity and frequency of hot flashes when compared with the potential risks. Specifically, gabapentin can cause dizziness and sleepiness, and paroxetine can cause nausea and has been shown to increase the risk of suicide.

Women need non-hormonal drug therapy options

I’m extremely disappointed with the advisory panel’s decision for a couple of reasons. First, there’s currently no FDA-approved non-hormonal drug therapy for menopausal women experiencing hot flashes. So women who don’t want to take hormones or who can’t take hormones−usually breast cancer patients−have to rely on lifestyle changes and over-the-counter remedies to control their hot flashes. Second, women who experience disruptive hot flashes on a daily basis often experience a steady decline in their quality of life. These women find it extremely hard to get a good night’s sleep, to concentrate and to get comfortable, which often results in a great deal of personal and professional angst.

Are non-hormonal drug therapies an option for you?

Let me be clear, only your doctor can decide if a treatment option is right for you. And all medication use should be closely supervised by your doctor. I do, though, want to make you aware of the latest findings and research so that you can make intelligent, informed decisions. For more information about the gabapentin and paroxetine clinical trials, check out this article.

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