FDA lifts major warnings on hormone replacement therapy

The U.S. Food and Drug Administration (FDA) is eliminating the prominent “black box” warnings on many hormone replacement therapy (HRT) medications, signaling a major shift in how the treatment is viewed for menopausal women.

The decision affects products containing estrogen or progestogen, alone or combined, that are prescribed to treat troublesome menopause symptoms like hot flashes, mood swings and sleep difficulty, and to reduce bone fractures.

FDA Commissioner Dr. Marty Makary and other agency officials said the warnings—which have appeared on medication packaging—were based on outdated scientific data that has discouraged many women from receiving beneficial treatment.

The “black box” warnings were mandated after a 2002 clinical trial pointed to an increased risk of breast cancer, heart attack and stroke in women using HRT, reported NBC News.

But doctors have long argued that the trial was flawed because it looked primarily at women in their 60s and 70s and used a specific hormone formulation that is not widely prescribed today. Women typically begin HRT in their 40s or 50s when menopause symptoms begin and are most severe.

Dr. MargEva Cole, an obstetrician-gynecologist at Duke University in Durham, North Carolina, noted the psychological impact of the warnings.

“Our big concern about the black box warning is that a lot of women are excited about walking out the office and then go home and read the black box and then never start it, because they get scared,” she said.

Recent studies using current hormone formulations have not found the same increased risk of adverse events.

The FDA is now adding a recommendation that women who are considering systemic HRT (pills or patches) should start treatment before age 60 or within 10 years of the onset of menopause. Starting early may offer benefits like a reduced risk of cognitive decline and cardiovascular disease.

However, the agency noted that the decision to use HRT is between patient and doctor and not a universal solution.

Dr. Samantha Dunham, director of the Center for Midlife Health and Menopause at NYU Langone Health in New York City, said there are alternatives, such as cognitive therapy or non-hormonal medications.

While the broad black box warnings are gone, detailed information about specific risks will still appear in package inserts.

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