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HHS revises safety labels for three additional menopause hormone therapy products

Digilifetrends Published 1 min read

Key takeaways:

  • HHS approved updated labels for three estradiol transdermal patches.
  • The move builds on earlier efforts to remove outdated risk language from menopausal hormone therapy products, according to HHS.

HHS has approved updated labels for three more menopausal hormone therapy products.

According to an HHS press release, the agency acted through the FDA on estradiol transdermal patches from two applicants.

hormone therapy with syringe

The FDA previously approved labeling updates in February for six menopausal hormone therapy (MHT) products to better clarify risk-benefit information. The latest action extends that effort by allowing the removal of the same outdated risk statements from the black box warnings on the three patches, including references to breast cancer, cardiovascular disease and probable dementia.

HHS also provided an update on efforts to speed appropriate manufacturing changes that could expand the capacity and availability of MHT products in the U.S.

About a year earlier, the FDA began asking companies to submit proposed supplemental label revisions for their MHT products. Since then, 29 companies have submitted proposed changes. The agency said it is working quickly with applicants to act on those requests.

“FDA’s actions today are grounded in, and consistent with, a sustained commitment to women's health as a cross-cutting agency priority,” Kyle Diamantas, JD, acting FDA commissioner, said in the release. “We are equally committed to ensuring that when women and their doctors determine hormone therapy is right for them, they can access it. That means advancing both the most up-to-date labeling and access to treatment.”

* Editor’s note: This is a developing story. Check back for updates.

Sources/Disclosures

Source:

Disclosures: Diamantas is acting commissioner of the FDA.

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