FDA Approves Brisdelle to Treat Menopausal Hot Flashes
Hot flashes are one of the most bothersome symptoms associated with menopause, affecting more than three-fourths of all menopausal women. The FDA has approved a new type of medication to help women with the hot flashes associated with menopause.
Because menopause occurs when a woman’s body lowers production of the hormones estrogen and progesterone, one of the treatments to quell symptoms has been hormonal therapy. Unfortunately, estrogen therapy comes with health risks, including an increased risk of breast cancer, heart attack, stroke and blood clots.
“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,” said Hylton V. Joffe, MD MMSc, director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides women with the first FDA-approved, non-hormonal therapeutic option to help ease the hot flashes that are so common in menopause.”
Brisdelle (paroxetine), marketed by Noven Therapeutics LLC of Miami, contains a selective serotonin reuptake inhibitor similar to the antidepressant Paxil, but in a lower dosage. The medication contains 7.5 mg of paroxetine and is dosed once daily at bedtime.
Although the exact mechanism is not known for how Brisdelle works, two studies have found that postmenopausal women with moderate to severe hot flashes (occurring a minimum of seven to eight per day or for a period of 50-60 per week) had reduced symptoms over a 12 to 24 week study versus women taking a placebo.
The most common side effects in patients treated with Brisdelle were headache, fatigue, and nausea/vomiting. The medication will also contain a boxed warning about suicidality that must be included on all medications containing paroxetine. Additional warnings will include a possible reduction in the effectiveness of tamoxifen if both medicines are used together, an increased risk of bleeding and a risk of developing serotonin syndrome (signs include confusion, rapid heart rate and high blood pressure).
Consumers and health care professionals are encouraged to report adverse reactions from the use of Brisdelle to the FDA MedWatch Adverse Event Reporting program atwww.fda.gov/MedWatch or by calling 1-800-FDA-1088.
For women experiencing hot flashes who cannot take standard hormonal therapies, there are lifestyle and home remedies to help with the troublesome symptoms of menopause: