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:
• Cool hot flashes. Dress in layers, have a cold glass of water or go somewhere cooler. Try to pinpoint what triggers your hot flashes. For many women, triggers may include hot beverages, caffeine, spicy foods, alcohol, stress, hot weather and even a warm room.
• Get enough sleep. Avoid caffeine, which can make it hard to get to sleep, and avoid drinking too much alcohol, which can interrupt sleep. Exercise during the day, although not right before bedtime. If hot flashes disturb your sleep, you may need to find a way to manage them before you can get adequate rest. One tip from Grace Pien MD, an assistant professor of medicine at the University of Pennsylvania’s Division of Sleep Medicine - “Research shows that a cool bedroom—between 64 and 72 degrees—improves sleep, and it has the bonus of minimizing hot flashes.”
• Practice relaxation techniques. Techniques such as deep breathing, paced breathing, guided imagery, massage and progressive muscle relaxation can help relieve menopausal symptoms. You can find a number of books, CDs and online offerings on different relaxation exercises. One study, published in the journal Menopause, found that hypnosis may be an alternative therapy worth looking into.
• Eat healthy. Eat a balanced diet that includes a variety of fruits, vegetables and whole grains and that limits saturated fats, oils and sugars. Ask your provider if you need calcium or Vitamin D supplements to help meet daily requirements. You might also want to try soy products. A study published in the journal Menopause found that two daily servings of soy can reduce the frequency and severity of hot flashes by up to 26%.
• Don't smoke. Smoking increases your risk of heart disease, stroke, osteoporosis, cancer and a range of other health problems. It may also increase hot flashes and bring on earlier menopause.
• Exercise regularly. Get regular physical activity or exercise on most days to help protect against heart disease, diabetes, osteoporosis and other conditions associated with aging.
US Food and Drug Administration: "FDA approves the first non-hormonal treatment for hot flashes associated with menopause"
PubMed Health – Menopause
Mayo Clinic: Menopause