FDA approves first-ever drug to ward off hot flashes associated with menopause

A drug to treat hot flashes caused by menopause has been approved by the Food and Drug Administration (FDA).

The non-hormonal drug fezolinetant, sold under the brand name Veozah and developed by Japanese drugmaker Astella Pharma, will now be available by prescription to women in the US.

There are a number of supplements and hormones on the market to relieve menopausal hot flashes, but the new drug targets the cause of the hot flashes.

Each year, more than one million American women begin “the transition,” which researchers say also costs U.S. employers at least $27 billion annually through absenteeism and health care costs.

The drug treats moderate to severe vasomotor symptoms, such as hot flashes and night sweats.

Veozah, containing the active ingredient of fezolinetant, is designed to block a chemical that modulates nerve cell activity in the part of the brain that regulates body temperature.

Dr. Janet Maynard, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research, said: “Hot flashes due to menopause can be a serious physical strain on women and affect their quality of life. of life.

“The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”

Menopause occurs when a woman’s menstrual period permanently stops, marked by the point where a woman has not had one for 12 consecutive months.

During menopause, women slowly produce less of the hormones estrogen and progesterone.

It usually occurs between the ages of 45 and 55, with 51 being the average in the US and UK.

Each year, more than a million American women begin “the transition,” which can cause a host of debilitating symptoms from hot flashes, vaginal dryness, and even low self-esteem.

About 80 percent of menopausal women experience hot flashes, which include periods of sweating, flushing, and chills lasting several minutes.

A hot flash occurs as a result of a drop in estrogen levels, which causes your glands to release higher amounts of other hormones that affect the body’s thermostat, causing a sharp rise in temperature.

Some women who experience hot flashes, vaginal bleeding, stroke, heart attack, blood clots, or liver disease cannot receive hormonal therapy.

Veozah is not a hormone and instead targets the brain activity that causes hot flashes during menopause.

One 45-milligram pill should be taken once a day, with or without food, at the same time each day.

The most common side effects of Veozah are abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver transaminases.

Prescribing information includes a warning of elevated liver transaminase or liver damage.

Before taking the medication, women should have a blood test to check for liver damage or infection.

During use, patients should have blood tests every three months for the first nine months of taking the drug.

Women who develop symptoms related to liver damage, including nausea, vomiting, or yellowing of the skin and eyes, should contact their doctor.

Veozah should not be used with CYP1A2 inhibitors and patients with known cirrhosis, severe kidney damage, or end-stage renal disease should also avoid it.

a study estimated by the Mayo Clinic last month that menopause costs American employers at least $27 billion a year through sick days and healthcare costs.

Experts said the numbers show it is in employers’ best interests to improve menopause support in the workplace to reduce economic burdens such as menopause-specific sick leave and flexible working hours.