FDA deems HRT safe for menopause, removes black box warnings

The FDA has decided to remove “black box” warnings for hormone replacement therapy for menopause. PER Images/Stocksy
  • Currently, menopause symptoms are treated through lifestyle changes, alternative therapies, medications, and hormone replacement therapy (HRT).
  • In January 2003, the U.S. The Food & Drug Administration (FDA) issued “black box” warnings for HRT about the potential increased risk for certain health conditions.
  • Earlier this week, the FDA announced it would be removing these warnings from HRT products due to more recent research disproving these initial risks.

According to the European Institute of Women’s Health, about 25 million women around the world enter menopause each year.

Menopause is a natural occurrence for cisgender women ages 45 to 55, when their menstrual cycle ends, ending their reproductive years.

Past research shows that about 85% of womenTrusted Source experience a variety of symptoms during menopause, such as hot flashesvaginal drynesssleeping issuesdepressionmood swingsweight gain, and difficulty concentrating.

Currently, menopause symptoms are treated through lifestyle changes, alternative therapies like yoga and meditation, certain medications, and hormone replacement therapy (HRT), also called menopausal hormone therapy (MHT) or hormone therapy (HT)

In January 2003, the U.S. The Food & Drug Administration (FDA) issued “black box” warnings for HRT medications based on the results of the Women’s Health Initiative (WHI) study, with warnings about the potential increased risk for health conditions like breast cancerdementia, and cardiovascular disease when taking HRT.

Earlier this week, the FDA announcedTrusted Source it would be removing these warnings from HRT products due to more recent research disproving these specific risks.

Medical News Today spoke with five women’s health experts to find out more about what HRT is, what are the “black box” warnings being removed, and what does this mean for women’s access to HRT for menopause symptoms.

According to Susan Marie Pacana, MD, a minimally invasive gynecologic surgeon and OB/GYN at Hackensack Meridian Jersey Shore University Medical Center in New Jersey, and a Menopause Society Certified Practitioner, HRT is prescription estrogenprogesterone, and sometimes testosterone therapy prescribed for peri and/or postmenopausal women to replace the hormones that decline with menopause.

“The typical reasons for taking HRT include relief of symptoms such as night sweats, hot flashes, vaginal dryness, decreased libido, and mood changes,” Pacana added.

“During the menopause transition, the ovaries stop producing estrogen and progesterone which are the hormones responsible for reproduction, periods, and other important bodily functions,” Sherry Ross, MD, a board certified OB/GYN and Women’s Health Expert at Providence Saint John’s Health Center in Santa Monica, CA, explained to MNT.

How HRT can help menopause symptoms“Losing these important female hormones affect almost every organ in our body and are profoundly affected by their absence. A tsunami of bothersome symptoms occur that can be reversed and avoided if you are prescribed hormone therapy. Taking hormone therapy, including estrogen and progesterone can minimize the majority of disruptive symptoms experienced by women.”
— Sherry Ross, MD

“Decades ago, beginning around 1945, a product called Premarin, derived from the urine of pregnant horses, was commonly prescribed along with synthetic progesterone,” Prudence Hall, MD, an OB/GYN in private practice in Santa Monica, CA, and author of Radiant Again & Forever: Overcome Menopause & Restore Your Radiance, told MNT.

Today, we have far better, more natural options. The form of HRT I use is bioidentical, meaning these hormones are molecularly identical to those naturally produced by a woman’s body,” she said.