FDA Removes Black Box Label for Menopause Hormone Replacement Therapy

The FDA has removed the black box label for hormone replacement therapy (HRT) used to address menopause symptoms, according to an announcement today at a Department of Health and Human Services press conference. The approval of two new drugs for the treatment of menopause symptoms was also announced during the event.

The removal is based on an updated FDA review of HRT that shows it reduces cardiovascular disease by 30%-50%, Alzheimer’s by 35% and bone fractures by 50%-60%. This is a stark contrast to the early 2000s FDA decision to apply a black box label warning on HRT for menopause symptom management, citing the results of the Women’s Health Initiative study, which said HRT increased the risk of breast cancer diagnoses. The results, published in 2002,and the subsequent media coverage led to a precipitous decline in women using hormone therapy to relieve their menopause symptoms, a trend that’s had negative consequences for millions of women, according to Health and Human Services Secretary Robert F. Kennedy Jr.

“Since that decision, more than 50 million American women have been scared away from treatments that could have eased their suffering and extended their lives,” Kennedy said during the press conference. “Before the panic, one in four women used hormone replacement therapy and today, it's fewer than one in 20.”

During menopause, the ovaries produce less estrogen and progesterone. Symptoms can be debilitating, including weight gain, mood swings and night sweats. Symptoms occur in more than 80% of women and last on average eight years, according to FDA Commissioner Marty Makary, M.D., M.P.H., who also spoke at the event.

“HRT has saved marriages, rescued women from depression and prevented children from going without a mother,” Makary added. “The male dominated medical profession, let's be honest, has minimized the symptoms of menopause, and as a result, women's health issues have not received the attention that they deserve. More than 80% of women have notable severe symptoms lasting up to eight years.”

Menopause complications also include bone fractures, caused by an increased risk for osteoporosis, and genitourinary symptoms like urinary tract infections, which are not only uncomfortable, but they can also be deadly and expensive. Urinary tract infections cost an estimated $1.6 billion annually in the United States.

In addition to the removal of the black box label, two new drugs for menopause symptoms were recently approved by the FDA. The first is a generic form of Premarin vaginal estrogen cream, the first approval in more than 30 years for this form of therapy, and the second is a nonhormonal option approved to treat vasomotor symptoms, such as hot flashes.

“Estrogen is FDA approved for osteoporosis prevention, premature menopause and several symptoms of menopause, and while 80% will experience symptoms, only 5% receive treatment,” Kelly Casperson, M.D., a board-certified urologist, said during the event. “If a patient does get a prescription from her doctor and brings it home, nearly one in three will never use it because of the fear created by the incorrect warning label. Today, there is hope. Evidence now outweighs inaction. The FDA decision to remove the boxed warning is not just regulatory. It's revolutionary.”