News Flash: There is a new drug for hot flashes and it won approval from the Food and Drug Administration on Friday. It is the first nonhormonal drug and it offers a new alternative to menopausal women.
According to the National Institutes of Health, hot flashes, which can cause women’s faces and upper bodies to become flushed and lead to sweating, may affect as many as 75 percent of women going through the transition that causes their menstrual cycle to stop.
An advisory committee to the F.D.A. voted against approving the drug 10 to 4. Perhaps this had to do with the drug’s side effects, which included headaches, fatigue, and nausea or vomiting.
Noven Pharmaceuticals developed the treatment, which will be called Brisdelle. It consists of a low dose of paroxetine, which is used at higher doses in the antidepressant Paxil.
Why Paxil couldn’t be used to accomplish the same thing is perhaps fodder for a future article.
Before the development and approval of Brisdelle, treatments for menopausal hot flashes have all contained the hormone estrogen, sometimes combined with progestin.
One small drawback to the use of these treatments is that a 2002 study suggested that the combination of estrogen and progestin could increase the risk of cardiovascular problems and cancer.
Maybe a minor case of having headaches, fatigue, nausea and vomiting is not a bad alternative, after all.
Especially if you’d rather use a treatment for menopausal hot flashes, but cannot or do not want to use hormonal drugs.
Though the F.D.A. does not have to follow the recommendations of its advisory panels, it is highly unusual for it to approve a drug that receives a strong negative vote.
And, yet it did. While there was a need for a nonhormonal therapy, committee members who voted against it said Brisdelle was only minimally effective — besides those relatively “minor” side effects.
The F.D.A. didn’t bother explaining why it went against the panel’s recommendation. It just stated that it viewed Brisdelle as a useful treatment that had met its goals in clinical trials.
How well did the hot flash drug work?
In the clinical trials for Brisdelle, women started out with a median of about 10 hot flash episodes a day. Those who took the drug had a median of nearly six fewer episodes a day. A placebo group showed only a reduction of four or five episodes a day, one to two fewer than the group who took the Brisdelle.
This practically indistinguishable result caused many members of the advisory committee to say such an insignificant difference would not be meaningful to women.
Noven, based in Miami, is a subsidiary of Hisamitsu Pharmaceutical of Japan. In a astement, it said that Brisdelle would be available in November. It did not say how much the “wonder” drug would cost.
According to Dr. Joel Lippman, chief medical officer of Noven, 24 million women in the United States had moderate to severe hot flashes. Two-thirds of the women were not currently treating them.
Other “minor” side effects listed on Brisdelle’s label are that the drug can increase suicidal thoughts or behavior. This is language similar to that on the labels of other drugs containing paroxetine.
Also, users could experience an increased risk of bleeding, and possible reduction in the effectiveness of the breast cancer drug tamoxifen if both drugs are used together.
F.D.A. staff raised concerns ahead of a February meeting of agency advisers that the drug didn’t exhibit enough of a benefit to risk side effects such as suicidal thoughts.
Do the concerns raised by the advisory committee and the F.D.A. staff outweigh the potential usefulness of Brisdelle for the treatment of menopausal hot flashes?
Not, apparently, according to the F.D.A. and their recent news flash that there’s a new drug for hot flashes.
Written by: Douglas Cobb