Women across the country say they can't get estrogen patches filled at their local pharmacy, even as federal regulators maintain the drug doesn't meet the official definition of a shortage.

A survey by telehealth company Midi Health found 44% of women had difficulty filling an estrogen patch prescription in recent months. Of those who struggled, 40% said their menopause symptoms returned or worsened as a result, and 11% said they stopped hormone therapy altogether rather than switch to an alternative they weren't sure about.

Demand outpaced supply after a label change

The surge traces back to an FDA decision last November to remove boxed warnings that had long been attached to hormone therapy labels, a move doctors say unlocked years of pent-up demand from patients who had avoided the treatment out of fear. A spokesperson for manufacturer Sandoz told Reuters the resulting demand "cannot fully be met at present."

The American Society of Health-System Pharmacists, which tracks drug shortages independently of the FDA, currently lists 14 different brands or dosages of estrogen patches as being in short supply. The FDA's own shortage database tells a different story. In May, FDA Commissioner Marty Makary said the agency's data showed supply did not meet its formal threshold for a shortage, adding that "the industry has been able to keep up, but barely." A September update struck a more reassuring tone, with the agency saying it was working with all six estrogen patch manufacturers and that approved supply had "nearly doubled" over the past year.

THE INDUSTRY HAS BEEN ABLE TO KEEP UP, BUT BARELY

That gap between the official shortage list and what patients and pharmacists are actually seeing has fueled a patient advocacy campaign pressing the FDA to explain the discrepancy and formally add the patches to its shortage list, which can trigger additional manufacturing and import flexibilities.

Doctors say the stakes of the shortage are real: stopping hormone therapy abruptly can cause hot flashes and other menopause symptoms to come roaring back, while switching brands or delivery methods can introduce new side effects patients weren't prepared for. In the meantime, patients described in multiple local news reports calling around to several pharmacies, splitting prescriptions across different brands, or paying out of pocket for alternatives.

Industry analysts and physicians quoted in trade coverage have warned the squeeze could persist for up to three years as manufacturers scale up production lines. For now, the FDA says it continues to monitor the situation, while telling patients who can't find their prescription to talk to their doctor about temporary alternatives rather than go without treatment entirely.