Blister packs of hormone replacement therapy medication. (Getty photos)

WASHINGTON — The U.S. Food and Drug Administration announced Monday it plans to remove warnings from hormone replacement therapy drugs that can be used to address symptoms of menopause, saying the statements are no longer needed. 

The black box warning, the strongest caution possible from the FDA, was added in the early 2000s after a study from the Women’s Health Initiative showed an uptick in rates of blood clots, breast cancer, heart attacks and strokes for women who used certain types of hormone replacement therapy. 

FDA Commissioner Marty Makary said during a press conference the change for estrogen-related products “is based on a robust review of the latest scientific evidence.”

Makary rebuked the medical establishment for not putting enough effort into researching women’s health conditions, including menopause. 

“A 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. How could the medical establishment get it so wrong for so long?” Makary said. “Women deserve the same rigorous sciences as is used for men.”

Study criticized

Department of Health and Human Services Advanced Research Projects Agency for Health Director Alicia Jackson said the black box warning on estrogen was based on “the flawed, overgeneralized and misinterpreted WHI study.” 

Jackson said menopause leads to a series of complicated and often painful experiences for women, including “sleepless nights, derailed careers, painful sex, broken bones and a loss of wellbeing.”

Jackson explained that when the level of estrogen drops throughout and after menopause, “a cascade of disease and aging begins.”

“A preponderance of data now shows that estrogen, when started early, acts as a protective shield for the brain, lowering risks of memory loss, mental health decline and neurodegenerative disease, even Alzheimer’s,” Jackson said.  

Makary said women should talk with their doctors and can request their estrogen levels be monitored as they approach the age where menopause typically begins and throughout that years-long process. 

He said that sometimes doctors can prescribe microdosing for hormone replacement therapy, followed by a half-dose and eventually a full dose as a woman’s estrogen levels decrease over time. 

Makary didn’t say how many of the companies that produce hormone replacement therapies plan to remove the black box warning but said he expects nearly all will do so. 

“Companies are, generally speaking, very excited when the FDA tells them they can remove a scary warning on your product,” he said. 

Review by panel

The FDA’s process for removing the black box warning requirement, Makary said, began with an expert panel earlier this year. The FDA’s subject-matter experts then conducted a “comprehensive review of the literature” and recommended the agency remove the requirement, which Makary accepted. 

The scientists who were part of the expert panel, he said, have written an article that will be published in the Journal of the American Medical Association.

President of the American College of Obstetricians & Gynecologists Steven J. Fleischman wrote in a statement that he “commends the HHS leadership for improving the lives of perimenopausal women by making the estrogen products they need more accessible to them.”

“The modifications to certain warning labels for estrogen products are years in the making, reflecting the dedicated advocacy of physicians and patients across the country,” Fleischman wrote. “The updated labels will better allow patients and clinicians to engage in a shared decision-making process, without an unnecessary barrier, when it comes to treatment of menopausal symptoms. ACOG has long advised clinicians to counsel patients based on an individual’s unique risk factors and treatment goals; this announcement does not change ACOG’s guidance on estrogen therapy.”