Anti-Depressant Drug Approved For Treatment
of Hot Flashes! Here They Go Again!
The FDA recently approved a drug to treat the symptoms of hot flashes, which offers a “NEW” alternative to menopausal women. However, this move is not without controversy.
This treatment is a new version of an old drug called Paxil which is an SSRI (an anti depressant). The agency’s panel of physician experts voted in March 2013 to reject the treatment because the drug did not offer enough symptom relief to warrant exposing patients to the risk of side effects such as increased suicidal thoughts, bleeding, and high blood pressure.
Unlike its independent panel, the FDA saw a need for at least one non-hormonal drug to reduce common menopausal symptoms. The new drug is called Brisdelle. “There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments,” Dr. Hylton Joffe, a director in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Gynecologists have been prescribing antidepressants such as paroxetine for years off-label to help alleviate night sweats and hot flashes in women plagued by sleepless nights. “The most effective treatment we have is estrogen, but in my experience, antidepressants can help a little bit,” said Dr. Isaac Schiff, Chair of Gynecology at Massachusetts General Hospital.
Paroxetine is typically prescribed in doses ranging from 20 to 50 milligrams per day to treat clinical depression, but Brisdelle contains just 7.5 milligrams, to be taken once a day at bedtime.
Antidepressants for hot-flash relief may be most useful for breast cancer patients who often can’t take estrogen drugs because they’re associated with an increased breast cancer risk. But now, with this new anti-depressant they will still run the risk of suicidal thoughts, bleeding, and high blood pressure.
In clinical trials testing Brisdelle’s effectiveness, the drug was found to reduce the number and severity of hot flashes compared with a placebo. However, the difference was small resulting in only about two fewer hot flashes per day. Women had to experience at least seven hot flashes a day to be included in the studies, so a reduction down to five isn’t all that significant, considering the side effects.
Side effects (according to Brisdelle's label) include: Increase in suicidal thoughts or behavior, increased risk of bleeding and may possibly reduce the effectiveness of the breast cancer drug Tamoxifen when used in conjunction with it.
The advisory committee to the FDA voted against Brisdelle’s approval 10 to 4 in March, 2013. So how does a drug with these findings get approved?
Although the FDA doesn’t have to follow the recommendations of its advisory panel, it is unusual for a drug receiving such a negative vote to be approved. It remains a mystery as to the motives for approving such drugs when there are safer alternatives, such as natural progesterone and nutritional supplements to help relieve menopausal symptoms.
Some information obtained from an article in The Boston Globe - July 2, 2013