The U.S. Food and Drug Administration (FDA) announced plans Nov. 10 to remove the black box, the most serious safety warning, from menopausal hormone replacement therapies (HRT).
HRT treats common symptoms of menopause, such as hot flashes and mood swings, by replenishing the key hormone estrogen, production of which slows at the onset of menopause. Although the FDA previously mandated black box labels that clearly communicate the risks of HRT — such as increased chance of blood clots and heart disease — the agency will move to instead note such risks on a packaging insert.
It is not uncommon for the FDA to change course on its classification of drugs, but the HRT decision is distinct in its comparative lack of rigor.
Charlotte Philips (CAS ’28), a biology of global health student, said a small “panel” of experts made the decision to alter HRT warnings in July, though the agency typically forms advisory committees of a wide range of experts.
“It’s reassuring to still see experts involved, but the new format creates a lack of transparency, which creates a little more skepticism, which you don’t want when you’re making potentially life-changing decisions in deciding to prescribe or take a medication like this,” Philips told The Hoya.
FDA Commissioner Marty Makary stated the decision to move away from traditional advisory committees came from their “bureaucratic” and inflexible nature, and that panels will allow for equally rigorous and more “spontaneous” decisions.
Ellie Ward (CAS ’28) said she worries that shortening key scientific discussions may lead to incomplete, hasty recommendations.
“I feel like women’s medicine is already so unstudied and women are underrepresented in clinical research already, and this feels like pushing more in that direction,” Ward told The Hoya. “It’s a little scary as someone who’s interested in science and also will need to feel secure about my choice to take these medications in the future if I need to.”
Full Disclosure: Ellie Ward currently serves as a Science columnist for The Hoya.
Philips said the removal of the black box may also lead to more women considering HRT as an option for relief from menopause symptoms.
“Menopause symptoms are usually not taken very seriously, but they can deeply affect women’s livelihoods,” Philips said. “Changing the warning label could lead women to ask their doctors about a treatment that could really improve their lives, and maybe help doctors consider it as an option.”
Ward said that though the decision will likely reinvigorate discussion around potentially beneficial HRT treatments, patients should still be cautious and thorough when deciding whether HRT is right for them.
“I hope that this decision will help patients look more into this care option and that doctors can support them to make the best choice, while still thoroughly considering the dangers,” Ward said.
