FDA Removes Warning on Hormone Therapy

The hormone therapy news from the Food and Drug Administration on Nov. 10, 2025 is one internists, urologists, endocrinologists and gynecologists have been wanting to see for decades.

Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, M.D., M.P.H. made the announcement at a press conference at HHS with more than 200 people in attendance. That included Second Lady of the United States Usha Vance and Secretary of Labor Lori Chavez-DeRemer.

“The experts knew it was wrong, but we couldn’t convince the federal government,” said Dr. Richard Bloy, hormone replenishment expert and surgeon for Contemporary Health Center. “But now, those in authority did their research, listened to specialists and removed the ‘black box’ warnings.”

The report said, “Women may be under-utilizing approved therapies that can alleviate menopause symptoms and improve women’s health because of U.S. Food and Drug Administration (FDA) ‘black box’ warnings about the risks associated with these drugs that the agency is removing.”

Women have used HRT products for decades to relieve menopausal symptoms, according to HHS. However, their use plummeted in the early 2000s when the FDA applied boxed warnings following a Women’s Health Initiative study that found a statistically non-significant increase in the risk of breast cancer diagnosis.

The black box warning contained misleading references to risk of cardiovascular disease, breast cancer and probable dementia.

The average age of women in the study was 63 years — over a decade past the average age of a woman experiencing menopause — and study participants were given a hormone formulation no longer in common use.

With women denied HRT by some doctors – partially in fear of being sued – as many as 91,600 postmenopausal women over a 10-year period, ages 50-59 years old, died prematurely because they were denied estrogen.

“We specialists knew it was wrong then,” Dr. Bloy said. “None of this stopped us from using hormones. None. Not for one second. But a lot of other women suffered when their doctors didn’t give them the therapies.”

The FDA is initiating removal of the boxed warnings following a comprehensive review of the scientific literature, an expert panel in July, and a public comment period. The agency is working with companies to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer and probable dementia.

Dr. Bloy said it’s important for HRT specialists to share the FDA’s report with various physicians. At a recent Androgen Society Conference, Dr. Bloy attended this past July, specialists from around the world said doctors are doing their patients a disservice if they don’t alert them to this therapy.

“This is a key first step,” Bloy said. “Now that it’s legally not wrong, we need to get the word out. The biggest impact can come from the physicians. They can now share this information with their patients freely and without repercussions.”