Estradiol Hormone Patch Shortage Strains Pharmacies After Warning Lifted

Authored by Jill McLaughlin via The Epoch Times,

Some U.S. pharmacies are scrambling to fill estradiol transdermal patch prescriptions as demand for the menopause treatment continues to soar following the Trump administration’s decision to remove what it determined was an outdated cancer warning.

“Manufacturers have been unable to provide sufficient supply of hormone replacement therapies [HRT] over the last several weeks,” CVS pharmacy spokeswoman Roslyn Guarino told The Epoch Times March 9.

In November, the Food and Drug Administration (FDA) started the process of removing the so-called “black box warning” from estrogen and estrogen-progesterone replacement therapy added in 2003, ending more than two decades of fear that the treatments increased risk of breast cancer.

As a result, estradiol transdermal patch prescriptions have increased by about 86 percent since 2021, according to the latest study by Epic Research.

CVS pharmacies—the largest U.S. chain—are working with patients to make sure they have access to their medications when the interruptions occur, Guarino said.

Sandoz and Amneal Biosciences, two major producers of estradiol transdermal patches for the U.S. market, listed 10 transdermal patch products currently affected by the shortage. Neither manufacturer gave reasons for the shortages.

Sandoz said the company takes the current supply situation “very seriously” and is making adjustments to meet the demand.

“Recent changes in prescribing behavior due to the FDA’s removal of boxed warnings on HRT patches have created an unprecedented demand that cannot be fully met at present,” Sandoz spokeswoman Jeanne LaCour told The Epoch Times in an email.

“We know this situation is frustrating and inconvenient for the women who rely on these patches. As a global leader in affordable medicines, Sandoz cares deeply about the well-being and health of the women who rely on these treatments. We are working on increasing global capacity to ensure adequate supply of HRT transdermal patches and to support continuity of treatment for patients around the world.

“In the interim, to help women in the U.S. specifically, we have allocated additional quantities to the States to better meet the increase in demand,” LaCour added.

Amneal Biosciences did not immediately return a request for comment.

Viatris, Noven, and Zydus had available product, according to the latest report.

“For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of [hormone replacement therapy],” U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy said in a statement about the decision.

“We are returning to evidence-based medicine and giving women control over their health again.”

The warning was preventing millions of women from receiving the life-changing and long-term health benefits of hormone replacement therapy, according to FDA Commissioner Marty Makary.

Studies show that women who start the therapy within 10 years of the onset of menopause, usually before the age of 60, can reduce all-cause mortality and bone fractures. They may also lessen the risk of heart disease by half, and Alzheimer’s disease by a third, the FDA reported.

The president of the American College of Obstetricians and Gynecologists (ACOG), Dr. Steven Fleischman, applauded the decision to remove the black box warning, saying the organization has long advocated for its removal on low-dose vaginal estrogen because of the barrier it posed for people who suffered from menopause symptoms.

Health Secretary Robert F. Kennedy Jr.in Washington on Jan. 7, 2026. Alex Wong/Getty Images

“ACOG commends the HHS leadership for improving the lives of perimenopausal women by making the estrogen products they need more accessible to them,” Fleishman said. “The modifications to certain warning labels for estrogen products are years in the making, reflecting the dedicated advocacy of physicians and patients across the country. The updated labels will better allow patients and clinicians to engage in a shared decision-making process without an unnecessary barrier, when it comes to treatment of menopausal symptoms.”

Dr. Sharon Winer, a reproductive endocrinologist at Cedars-Sinai Medical Center in Los Angeles, said patients should be cautious about the decision.

“The FDA ruling gives clinicians and patients space to individualize care, but it’s not a license to assume [menopause hormone therapy] is universally beneficial,” Winer said. “The FDA’s action is progress, but it doesn’t mean [menopause hormone therapy] will solve every aging-related concern. There’s a lot we still don’t know.”