New Drug for Hot Flashes Gains FDA Approval

Another Mother’s Day has come and gone.  This year moms around the age of 50 were likely hoping for a good night’s sleep for once, and relief from perimenopausal symptoms like hot flashes.  With greater awareness about menopause and its many disruptive symptoms, researchers have finally received FDA (Food and Drug Administration) approval for the first non-hormonal medication to treat moderate to severe hot flashes

The menopausal phase in a woman’s life, which usually occurs from the mid to late 40s to early 50s, can last as long as seven years.  During this period, many women experience hot flashes and overheating that can significantly impact their quality of life, disrupt sleep, and interfere with work.  According to a recent New York Time Health report, these “power surges” affect at least 60 percent of women. 

Although recent research has found hormonal treatments including estrogen and progestin have much lower risks for blood clots and strokes for women in their 40s and 50s than previous studies suggested, many doctors and patients are still wary of these treatments.  Severe hot flashes and other symptoms are very real and can take a significant toll on women at work and home – especially when they are dismissed.  Many women in menopause today are done keeping silent and are more openly discussing and busting the myths and stigma surrounding menopause and its often unpleasant side effects. 

The new drug, which will be marketed as Veozah, targets a neuron in the brain that becomes unbalanced when estrogen levels fall during the menopausal years.  In studies, the drug was found to be effective and generally safe.  The FDA lists side effects that included stomach pain, diarrhea, and insomnia.   Before prescribing Veozah, clinicians should run patient blood tests to rule out existing liver problems and continue to test for the first nine months of use, as signs of liver damage emerged in some patients during the drug’s trials.   Signs of liver damage can include nausea, vomiting or yellowing of the skin and eyes – seek immediate medical help if these symptoms occur while taking the drug. 

Veozah is expected to be available in U.S. pharmacies within three weeks, but the costs of $550 for a month’s supply could be prohibitive.  The drug manufacturer, Astellas, is planning to launch a support program to help patients affordably access the medication.