Hot flashes are no fun, and that’s putting it mildly. Hormone therapies can reduce hot flashes, but have serious dangers, including breast cancer. Does Brisdelle work? What are the reasons to consider it, and why should you think twice before taking it?
Brisdelle is the brand name for paroxetine, which is also another name for Paxil, a widely used anti-depressant. The only difference is that it looks different – it’s a different color. If you take Brisdelle for hot flashes you are paying much more money for an anti-depressant that has serious side effects.
Most importantly, Brisdelle doesn’t work. In the studies conducted by the company that makes Brisdelle, the frequency of hot flashes decreased after taking it for 4 weeks, but in some studies there was no improvement after that.
If Brisdelle were completely safe, some women might want to try it to see if it works for them. But, women who were not depressed before taking Brisdelle for hot flashes were more likely to have suicidal thoughts and behaviors than the women taking placebo. This was true even on the small dose of 7.5 mg.
Yes, you read that right. Even though Brisdelle is also an antidepressant, it can cause women to feel suicidal and even to try to kill themselves.
This is an especially serious problem in the United States, because women between the ages of 45-54 have the highest rates of suicide in the U.S. That is the same age group most likely to take a drug for hot flashes.
There are other bad side effects as well, such as anxiety, mood swings, diarrhea, nausea, and loss of libido. Some women feel very agitated or even have trouble breathing. And if a patient starts and then stops taking the drug, they tend to suffer muscle complaints, fatigue, restless feelings in the legs, and disrupted sleep.
You might wonder why the FDA approved this drug, despite its unimpressive benefits and very real risks. That’s a good question – especially since the FDA’s Advisory Committee of scientists and physicians recommended against the drug. It’s easier to understand when you realize that the FDA says that just because they approve a drug doesn’t mean that they think it is a good idea to take it. Their criteria are much lower: they approve a drug if they think some patients will benefit more than those patients will be harmed. Even then, the agency has made some bad mistakes, and they are especially likely to do that when a drug is already approved for another purpose, as Paxil (Paroxitene) is.
In summary, the risks of Brisdelle include many of the same symptoms as menopause, and if a woman stops taking it, she may suffer even more. Even if you are one of the few women to have fewer hot flashes as a result of taking Brisdelle, is it worth feeling nauseous and moody, and then having even more side effects when you stop taking the drug?
For our Center’s testimony before the FDA on this drug in 2013, see http://center4research.org/public-policy/testimony-briefings-statements/jennings-testimony-paroxetine/
For other ways to cope with hot flashes, see here.
All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.