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FDA approves first nonhormonal hot flash treatment

by Margery Gass | Jul 03, 2013
Good news for women who have been waiting for an effective nonhormonal treatment for hot flashes: the FDA has just approved the very first nonhormonal therapy in the history of menopause. We have known for awhile that some antidepressants provide relief from hot flashes, but not one was officially approved for that purpose. The newly approved product will be a lower dose of an antidepressant first approved 20 years ago (paroxetine, brand name Paxil). The lower dose approved for hot flashes is called Brisdelle and will probably be available in November. Women who have not found sufficient relief for their moderate or severe hot flashes from lifestyle measures will now have one more option to discuss with their healthcare provider.

Until now, hormone therapy was the only FDA-approved treatment for moderate to severe hot flashes. Some women cannot use hormone therapy for medical reasons or simply prefer not to use it. Brisdelle provides another choice. Although it may not reduce hot flashes as effectively as hormone therapy, it will decrease flashes for most women. Like other drugs, it will not meet the needs of every woman.

Every drug comes with risks and side effects: In clinical trials studying how the drug affected menopausal women, side effects included headache, fatigue, and nausea/vomiting, most commonly occurring in the first week. The label also carries the warning of all antidepressants in this class, that of potentially increasing suicidal thoughts or behavior in the first few months. There is also a possible reduction in the effectiveness of the breast cancer drug tamoxifen if the drugs are used together.

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  1. 3 HMM 05 Jul
    RUN!!!  Run as far away from this drug as you possibly can.  Hot Flashes are like a Hawaiian Vacation compared to the withdrawal symptoms you can experience.  Be very, very careful...
  2. 2 Lucy Puryear 10 Jul
    Even though it is the first FDA approved drug, there is nothing new about the use of paroxitene for the treatment of hot flashes.  Many of the SSRI's and SNRI's have been studied and show some reduction of hot flashes in some women.  This is same medication found in the brand name Paxil, only prescribed in a lower dose than typically used for depression.  This same treatment could be accomplished more cost effectively by prescribing paroxitine at 10 mg.  There is nothing new about this.
  3. 1 Haley Anthony 31 Oct
    Hello! I am working with my business capstone group to develop a business specifically for menopausal and post-menopausal women. We have a survey to gather primary research to hear women's opinions, reactions, and personal experience with menopause. If you have 5-10 minutes to spare, please take our survey so we can have more results! Thank you!



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JoAnn V. Pinkerton, MD, NCMP
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