FDA Approves New Treatment For Hot Flashes Associated With Menopause

Menopause affects every woman differently; in fact, 50% of women never suffer symptoms such as hot flashes.The drug, available sometime this fall, is the first non-hormonal treatment approved for hot flashes – significant for patients whocan’t take drugs containing estrogen.Other available FDA-approved treatments for hot flashes all have either estrogen alone or a combination of estrogen and progestin.Brisdelle’s active ingredient, paroxetine, has been used as an “off-label” treatment for years, meaning that physicians have used it for something other than its intended use as an anti-depressant.

In 2003 the FDA approved paroxetine as an anti-depressant. That same year the Journal of the American Medical Association published the results of a pilot studyinvolving 165 menopausal women that showed paroxetine to be helpful in controlling hot flashes and night sweats.”This will fill a gap for many women and their clinicians,” said Dr. Margery Gass, president of the Cleveland-based North American Menopause Society. “I think it’s a welcome arrival so we have more options.”Some women start having hot flashes when they start menopause (either naturally or caused by surgery or certain medications), while others begin experiencing them in the years leading up to menopause.

“By far, the most effective treatments are those with drugs that have estrogen,” said Dr. Thomas Frank, director of the OB-GYN residency program for MetroHealth Medical Center and the Cleveland Clinic, and associate professor at Case Western Reserve University School of Medicine. “But hormones aren’t ideal for everybody.”Women who have been treated for breast cancer or who have blood clotting issues in their legs or lungs aren’t good candidates for estrogen.More than 1,000 women with moderate to severe hot flashes (at least seven per day or 50 per week) were enrolled in two randomized, double-blind, placebo-controlled studies. In one study, women took the drug for 12 weeks. In another, they took it for 24 weeks.

The hormone therapy tamoxifen used to treat some breast cancer patients often brings about hot flashes because it’s used to inhibit the growth of cancer cells fueled by estrogen.Because that patient population wasn’t included in the Brisdelle study population, it’s impossible to know what effect Brisdelle – even at lower doses – has.Because Brisdelle shares the same active ingredient as some anti-depressants, it will carry the same label warnings as those drugs. Those warnings include possible reduction in tamoxifen effectiveness, increased risk of bleeding and increased risk of suicide. Hot flashes in women don’t only happen during menopause.

In June, the journal Menopause, the journal of the North American Menopause Society, published a study showing that about 55 percent of middle-aged women aged 45 to 56 who still have regular menstrual cycles have hot flashes. The findings were based on a survey of 1,500 women, conducted by researchers from the Group Health healthcare system and the Fred Hutchinson Cancer Research Center, both in Seattle.