Federal health officials on Oct. 30 said they have approved removing high-level warnings about heart problems and other health issues from patches women use to treat menopause symptoms.
The Food and Drug Administration approved removing so-called black box warnings from three estradiol transdermal patches, which provide women with the estrogen hormone, according to the FDA’s parent agency, the Department of Health and Human Services.
Black box warnings are the strictest level of warnings the FDA issues.
The warnings had alerted women that they could face an increased risk of cardiovascular disorders, probable dementia, and breast cancer. The labels still say the products could increase the risk of breast cancer, dementia, and cardiovascular problems.
The products are Minivelle, Vivelle, and Vivelle-Dot.
Health officials said the move supported President Donald Trump’s recent order establishing a women’s health task force and a new division at the health department focused on women’s health.
“Removing outdated statements from these boxed warnings marks a major victory for women’s health,” Health Secretary Robert F. Kennedy Jr. said in a statement on Friday. “Under President Trump’s leadership, we are changing how the federal government approaches menopause care. We are updating labels to reflect current science, confronting barriers to treatment, and working with manufacturers to expand supply.”
“FDA’s actions today are grounded in, and consistent with, a sustained commitment to women’s health as a cross-cutting agency priority,” acting FDA Commissioner Kyle Diamantas added. “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.”
The changes were a result of reexamining relevant scientific data and other updated information, according to the health department.
Menopause refers to when a woman’s menstrual period ends. It usually starts with a transitional phase called perimenopause when a woman is in her mid-40s.
The process lasts years and can include symptoms such as difficulty sleeping and hot flashes.
The FDA has since 2025 been working with manufacturers on updated labels for menopausal hormone therapy products, and 29 companies have since filed proposed labeling changes.
In February, the FDA approved removing the same black box warnings from six of the products, including a topical vaginal estrogen therapy called Estring that is manufactured by Pfizer.
The products, which include gels and creams, have become more popular in recent months. Companies told The Epoch Times previously that manufacturers had been unable to provide sufficient supply for a period of time.
Health officials said that there are no signs of an imminent nationwide shortage and that manufacturers have stepped up production in response to the increased demand.
“Women who are having difficulty finding their usual patch product are encouraged to speak with their pharmacist or healthcare provider, who may be able to identify an available alternative or equivalent option appropriate for their individual needs,” the Department of Health and Human Services said on Friday. “Availability can vary by brand, strength, formulation (once-weekly versus twice-weekly), and geographic location.”
