Scripted for Her: HRT Black Box Removal

In episode 8 of Scripted for Her, Natalie DiPietro Mager, PharmD, PhD, MPH, sat down with Karen Kier, PhD, RPh, BCPS, BCACP, and explored the FDA’s recent removal of a black box warning label for hormonal replacement therapy (HRT) to treat menopause.

“It was just last month that the FDA announced this reversal and that has sparked a lot of attention in the press,” said Mager in her introduction of the episode. “I thought it would be good for us to provide some historical perspective on how we got to the black box warning in the first place, the implications for its removal, and other potential treatment options for patients.”

The December installment of Scripted for Her details the FDA’s early November announcement that enforced the removal of black box warnings from HRT products used for menopause. According to the FDA and US Department of Health and Human Services, HRT products were previously surrounded by fear and misinformation, leading to a need to remove the warning.¹

However, what will this event mean for women in the future as well as the pharmacists that manage their prescriptions and treatment regimens?

Kier is a professor of clinical pharmacy and director of the Drug and Health Information Center at Ohio Northern University. She joined Mager in this month’s episode to add nuance to the FDA’s recent action in the women’s health space and how pharmacists can be ready to tackle any patient concerns following the warning’s removal.

Scripted for Her, a podcast from Drug Topics hosted by Natalie DiPietro Mager, PharmD, PhD, MPH, professor of pharmacy practice at Ohio Northern University, aims to help pharmacists provide comprehensive care and continuity of care within the women’s health space. All episodes of Scripted for Her are available in video format via DrugTopics.com on the third Wednesday of each month. Check out our most recent episode, Smoking Cessation for Women.

READ MORE: Women’s Health Resource Center

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REFERENCE

HHS advances women’s health, removes misleading FDA warnings on hormone replacement therapy. News Release. FDA. November 10, 2025. Accessed December 16, 2025. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy