(RxWiki News) In early menopause, women can experience a fast heart rate, sweating and hot flashes in their face and upper body. A certain antidepressant may offer relief.
"Ask your doctor about relieving hot flashes."
However, this drug has not been approved by the FDA for relieving hot flashes and the manufacturer, Pfizer, withdrew its application for the drug’s approval for these symptoms. The company did not provide an explanation.
JoAnn V. Pinkerton, MD, lead author for the study and Medical Director of Midlife Health Center and Professor of Obstetrics and Gynecology, University of Virginia in Charlottesville, and her colleagues noted improvements in patients having 50 or more hot flashes per week.
The 12-week study was conducted with 365 women who were experiencing bothersome moderate-to-severe hot flashes. Desvenlafaxine was given to 184 women and a placebo (fake pill) was given to 181.
Investigators noted that 100 milligrams per day significantly reduced the severity of symptoms in the drug group compared with the placebo group.
Women in both groups were having an average of 12 hot flashes per day. At week 4, women in the PRISTIQ-treated group experienced a 55 percent reduction in hot flash frequency. These women had an average of 6.5 fewer hot flashes per day.
The placebo patients had a 31 percent reduction in hot flash frequency, or an average decrease of 3.6 flashes a day.
At week 12, women in the PRISTIQ group had a 62 percent reduction in hot flash frequency contrasted with a 38 percent reduction in hot flash frequency in the placebo group.
Women receiving the medication also had less severe symptoms. Negative events reported during the 12-week study were nausea, dry mouth, fatigue, constipation, diarrhea and drowsiness.
“Desvenlafaxine significantly reduced the number and severity of moderate-to-severe hot flashes among postmenopausal women compared with placebo, which is meaningful because up to 75 percent of women experience hot flashes associated with menopause,” said Dr. Pinkerton.
PRISTIQ is approved by the U.S. Food and Drug Administration for the treatment of major depressive disorder in adults.
This non-hormonal therapy is not approved by the FDA for the treatment of moderate-to-severe vasomotor symptoms (hot flashes and night sweats due to menopause).
For women with severe menopause symptoms, hormone replacement therapy with estrogen had been shown to be effective.
Some studies, however, have raised concerns that hormone therapy might increase the risk of breast cancer or heart disease.
Desvenlafaxine belongs to a class of medicines known as serotonin-norepinephrine reuptake inhibitors (or SNRIs).
Camran Nezhat, MD, FACOG (Fellow of the American College of Obstetricians and Gynecologists), told dailyRx News, "Menopause is a change that all women go through, however each woman is affected differently, sometimes significantly. Some women have symptoms so severe that it impacts their quality of life. Serotonin-norepinephrine reuptake inhibitors have been shown to help women with menopausal symptoms and offers physicians and patients another option to help improve women's lives."
This study was published in the September issue of Menopause, the journal of the North American Journal Society. Pfizer is the manufacturer of PRISTIQ and supported this study.