FDA approves nonhormonal treatment for hot flashes

astewart@newsobserver.comJuly 8, 2013 

Dr. Patricia Moorman.


  • Hot flashes and menopause

    • Menopause occurs when ovaries stop producing estrogen and progesterone and a woman’s menstrual periods stop. The average age for menopause is 51, but for some women it happens as early as 40 or as late as 55.

    • Hot flashes are a sudden feeling of heat in the upper part or all of the body. The face and neck may become red and blotches may appear on the chest, back and arms. Heavy sweating and cold shivering can follow.

    How to treat hot flashes

    • Hormones: Estrogen and progesterone treatments are the most effective in preventing hot flashes. Women who have had a hysterectomy can take estrogen alone, but those who have not should take both hormones to prevent endometrial cancer. Estrogen therapy is not recommended for those with a history of blood clots or breast cancer.

    • Antidepressants: Venlafaxine, paroxetine or fluoxetine are useful for women who are unable or unwilling to use hormones to treat hot flashes.

    • Gabapentin: This anti-seizure drug is a “moderately effective” treatment for hot flashes, especially for nighttime symptoms.

    • Clonidine: Used as a pill or patch to treat high blood pressure, this medication can provide some relief from hot flashes.

    Source: womenshealth.gov, mayoclinic.com

    More information on Paxil


The Food and Drug Administration recently approved a new nonhormonal medication to relieve hot flashes and night sweats in women experiencing menopause. Brisdelle contains paroxetine, the active ingredient in the antidepressant Paxil. Some antidepressants can cause physiological and psychological changes when discontinued.

Brisdelle was approved despite an FDA panel voting against it.

Dr. Patricia Moorman, an associate professor in community and family medicine at Duke University, explains the new drug and what it means for women who suffer from hot flashes.

Q: Why do you think the FDA panel didn’t approve of Brisdelle?

I think that the initial thought was that the clinical trial showed a very modest benefit. Sometimes drugs work very well for some women and not at all for others. It’s just providing another option for women with hot flashes.

Q: Brisdelle contains 7.5 mg of paroxetine, which is slightly less than Paxil’s lowest dose. Is this going to make a significant decrease in the negative side effects associated with Paxil?

Doctors want to use the lowest effective dose for an indication. Response to drugs is very individualized. In the clinical trials, the side effects were headache, fatigue, nausea and vomiting, which are very common side effects for most drugs.

Q: How long has paroxetine has been prescribed by gynecologists for its off-label treatment of hot flashes?

Several years now. I think that I recall a clinical trial from about 10 years ago.

Q: Why would women be interested in this new drug?

There are many women who are unable or unwilling to take hormones. This is the first nonhormonal drug that treats hot flashes.

Q: Is Brisdelle more or less effective than other drugs that contain hormones and serve the same purpose?

They’re different drugs, but they do the same thing. One is not stronger than the other.

Stewart: 919-829-4568

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