AMARILLO, TEXAS — The Food and Drug Administration removed the black box warning from hormone replacement therapies in November, a decision the agency said has driven a sharp rise in demand for estrogen patches without yet meeting the threshold for an official shortage designation. Doctors and patients across the country have reported difficulty obtaining certain doses of the patches in the months since.

FDA chief Dr. Marty Makary said the November action prompted a tremendous increase in demand but not enough to cause a shortage. "The industry has been able to keep up but barely. They are recalibrating their distribution and manufacturing to have more robust supply. In the interim, the estrogen patches have not risen to the criteria of being on the shortage list, but it is something to manage," he said.

Inclusion on the FDA shortage list can trigger actions such as identifying alternative suppliers and extending expiration dates for drugs. The American Society of Health-System Pharmacists, which maintains its own separate shortage list, first added estrogen patches in January and currently includes 14 brands or dosages.

The rise in patch use predates the November decision. According to data from Truveta, estrogen patch use increased 26% by the end of February of this year, and has risen 184% since 2023, while vaginal cream use has climbed 122% over the same period.

"There's been a surge in demand for the last two or three years where the utilization of transdermal estrogen has gone up significantly," said Dr. Robert Kauffman, a professor of obstetrics and gynecology. He said there is a shortage in West Texas and that colleagues across the country are reporting them as well.

Dr. Kathleen Jordan, chief medical officer at Midi Health, said patients are increasingly facing problems filling estrogen patch prescriptions due to shortages at pharmacies. "This was happening occasionally last year but has escalated this year," she said. A spokesperson for Alloy Health said in an email that the company has not noticed an estrogen patch shortage affecting its patients.

Hormone replacement medications are prescribed to treat hot flashes, mood swings, urinary tract infections, vaginal dryness and difficulty sleeping, and to protect against bone fractures. In the early 2000s, hormone therapy use plummeted after the FDA placed a black box warning on estrogen products following a study by the Women's Health Initiative, which found women on hormone therapy had elevated risks of heart attacks, strokes and other cardiovascular issues. A reanalysis found that hormone therapy did not increase breast cancer risk above the baseline rate of one in eight women.