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Hot Flashes Stop but Brisdelle Side Effects Keep Going

Antidepressants like paroxetine have been re-purposed to treat hot flashes. Brisdelle is FDA approved, but you might want to know about side effects.

Have you seen the TV commercials for Brisdelle to ease symptoms of menopause?

The female announcer says:

“Are you dealing with hot flashes during menopause? Why suffer more than you have to? You can do something different. Because the landscape of options has changed.

“Brisdelle is the only FDA approved non-hormonal option proven to reduce moderate to severe hot flashes during menopause. And a bedtime dose provides 24-hour relief.

“Brisdelle is not for everyone. Call your doctor if you have changes in mood or behavior, thoughts of suicide, or a high fever, stiff muscles or confusion, signs of a possible life-threatening condition. Abnormal bleeding, bone fractures, restlessness, vision problems, and impaired judgement and motor skills may occur.

“Don’t take Brisdelle if you are pregnant, taking MAOIs, thioridazine, pimozide or are allergic to paroxetine. Tell your doctor about all your medicines like tamoxifen, triptans, or paroxetine. Side effects include nausea, vomiting, tiredness and headache…”

Even with the list of complications, the TV commercials are really appealing. People are smiling and having a good time even when the announcer mentions side effects. And there is a friendly dog to distract you. It’s no wonder women are interested in Brisdelle. Here’s what we heard from one reader:

Q. I saw a commercial for Brisdelle and wanted to know more since I have struggled with hot flashes and night sweats for way too long. Then I learned it has the same ingredient as the antidepressant Paxil.

I took Paxil some years ago for depression and when I stopped the withdrawal symptoms were horrific. I suffered “brain zaps;” it was the worst thing I’ve ever been through.

As a result, I won’t go near Brisdelle. The commercial says it’s the only non-hormonal option. Is that really true?

A. Brisdelle is the only non-hormonal drug that the FDA has approved for hot flushes. The maker might be emphasizing the non-hormonal angle because many women worry about hormone replacement therapy. Estrogen and progestin may raise the risk of breast and ovarian cancer, heart attacks, strokes and dementia.

The ad doesn’t mention that the active ingredient in Brisdelle, paroxetine, was originally prescribed as an antidepressant. Nor does it say that stopping paroxetine suddenly can be hard, as you discovered.

Most importantly, the commercial does not tell how well it works. The difference between Brisdelle and placebo was two fewer hot flashes per day. While that is statistically significant, it is hardly impressive, especially since women had to experience at least seven flushes a day to be included in the study.

Side effects of Brisdelle include headache, nausea, vomiting and fatigue. Suicidal thoughts may also occur on occasion.

There may be a side effect on the wallet as well. One woman said her Brisdelle bill was $178 for a month’s supply. A low dose of generic paroxetine, though not approved for hot flashes, runs about $4.

If you would like to learn more about other approaches to dealing with menopausal symptoms you may find our Guide to Menopause of interest. It discusses a number of non-drug options. You will get the straight and skinny on using antidepressants like paroxetine and learn more about unpleasant withdrawal symptoms. Here is a link.

Share your own story below about dealing with hot flushes. We are interested in both successes and failures. And please vote on this article at the top of the page.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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