FDA Approves New Drug for Menopausal Hot Flashes, Night Sweats

The newly approved medication should hit the pharmacies in a few weeks.

The United States Food and Drug Administration (FDA) has approved a new medication to treat hot flashes and night sweats among women experiencing menopause.

The newly approved pill, which hits the shelves as "Veozah," seeks to address one of the most common symptoms of menopause sans any hormonal therapy.

FDA Approves New Drug to Treat Hot Flashes, Night Sweats

Food and Drug Administration
WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. Sarah Silbiger/Getty Images

The vice president for BioPharma Developer of the drug maker, Astellas, Marci English, says that the recent approval should make the non-hormonal pill available to pharmacies in the next few weeks. It would enable women grappling with menopause to get a new treatment for frustrating hot flashes and night sweats.

However, NBC News notes that the new medication is less effective than the standard hormonal therapy treatment, which amazingly cools roughly 90% of hot flashes. Instead, the clinical trials of the drug show that it improved hot flashes by about 48% for those taking it in high doses. Meanwhile, the lower dose shows a 36% breakthrough.

A Columbia University Vagelos College of Physicians and Surgeons assistant professor of women's health, Dr. Mary Rosser, expressed her excitement about the latest FDA approval. Rosser, the director of Integrated Women's Health at Columbia, says, "[We are] talking about something that is going to be powerful."

She touts the new type of drug to be a "game-changer" for women out there since it no longer requires them to undergo hormone replacement therapy. It is also a terrific development for ladies who have previously undertaken treatment for cancers that are hormone sensitive, Rosser notes.

CBS News reports that roughly 80% of women between 40s and 50s encounter hot flashes. With the new medication, they can address the issue without going through hormonal therapy.

Veozah: Are There Side Effects?

According to CNN, the FDA issued a liver injury risk warning for the newly-approved drug, Veozah. And as such, women who are planning to get their hands on the medication must take a blood test beforehand. It should rule out any existing liver damage or infection.

Besides the blood test, the FDA also requires them to take blood tests after every three months to check for any signs of liver damage.

CNN reports that the studies of the newly FDA-approved drug show some of its common side effects. It includes possible abdominal pain, insomnia, and diarrhea. In addition, the medication may also trigger back pain and elevated liver enzymes.

The new medication has no effect on menopause symptoms such as weakened bones, vaginal dryness, and painful sex. Relief from heat flashes transcends mere comfort.

The clinical data revealed relatively few adverse effects, at least during the duration of the trials. Some participants had unusual liver function test results, but these markers returned to normal when the medication is discontinued.

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