Medicines To Treat Hot Flashes Rejected By F.D.A. Panel

Two drugs striving to become the first non-hormonal hot-flash treatment to win approval were roundly rejected by a panel of outside advisers to the Food and Drug Administration called the advisory committee for reproductive health drugs. The committee voted 10 to 4 against Noven Pharmaceuticals’ low-dose formulation of the antidepressant paroxetine. It also voted 12 to 2 against approving extended-release gabapentin, developed by Depomed. The F.D.A. is not required to follow the recommendations of its advisory panels, but it would be highly unusual for the agency to overlook a strongly negative committee vote and clear a drug afterward.

Over 50 percent of women going through menopause experience vasomotor symptoms, also known as hot flashes. Vasomotor symptoms are characterized by a sudden feeling of heat, often with sweating.  These symptoms can be disruptive to sleep, daily activities and relationships. The most effective treatments are considered to be the hormone estrogen or the combination of estrogen and progestin. However, use of these remedies has sharply decreased since a study released in 2002 revealed that the combination of estrogen and progestin could raise the risk of breast cancer and cardiovascular problems.

Many menopausal women are looking for an alternative to hormones for treating hot flashes. For women who now cannot or will not use hormones, there is an urgent need for treatment options. Doctors and patient advocates told the committee that many of these women resort to herbal supplements or other therapies that have not been proven effective. Dr. Andrew London, an obstetrician and gynecologist in the Baltimore area, told the committee that women "are begging for alternatives," and that if there were no approved drugs, "They will get help on their own without us."

While recognizing the need for new medications, members of the committee said both medicines offered only marginal benefits and reduced the number of hot flashes by only about one a day when compared to a placebo. Even though both drugs have previously been used for other diseases and have risks that are well known, the committee members were not convinced that the benefits outweighed the risks. Dr. Julia V. Johnson, chairwoman of the meeting and a professor of obstetrics and gynecology at the University of Massachusetts Medical School, said, "The risk of medications cannot be ignored for a treatment of marginal effectiveness."

Article Credit: http://www.healthaim.com/medicines-to-treat-hot-flashes-rejected-by-f-d-a-panel/