In November 2025, the Food and Drug Administration announced that hormone therapies for menopause would no longer carry a black box warning about serious risks such as heart attack, stroke and breast cancer.
That announcement triggered an increased demand for estrogen patchEstrogen patches are a form of hormone replacement therapy. They deliver a slow release of estrogen through the skin and into the bloodstream, and are prescribed primarily for menopause symptom relief, preventing osteoporosis and hormone deficiency. prescriptions — so much so that a recent Midi Health survey of nearly 8,000 women found that 44% of the participants reported difficulty filling their prescriptions. Of those women, 34% felt the estrogen shortage was impacting their well-being.
“I’ve heard of women going to different counties and sometimes different states (to get their patches),” said Barbara Marusiak, senior director of clinical research management and regulatory science for ASU’s Edson College of Nursing and Health Innovation. “And everybody is hitting the online pharmacies, too, whether it’s Amazon or somewhere else, trying to figure out where they can get the stuff.”
ASU News talked to Marusiak about the shortage, why the black box warning was removed and what options women have if they can’t get their patches. In addition, Eugene Schneller, a professor of supply chain management at the W. P. Carey School of Business, explained how a supply chain delay is factoring into the shortage.
Note: The following responses have been edited for length and clarity.
Question: For those who don’t know, what is a black box warning?
Marusiak: In clinical research, when we’re looking at drugs and having clinical trials, we sometimes find they cause adverse events for a certain amount of people. At a certain point, we may see life-threatening events that could complicate a patient’s treatment plan. So the FDA thought, what if we put a black box around the label and bring attention to it. It was strictly for clinicians at the time, but patients could see it too. It was to bring attention to serious adverse events. It doesn’t mean that the drug is dangerous for all.
Q: So, why was the black box warning removed for estrogen patches?
Marusiak: In about 2003, the Women’s Health Initiative, based on some studies and some clinical trials that were going on, said, “Oh my gosh, pure estrogen is causing things like breast cancer, high blood pressure and cardiac issues.” So they made a black box for around the label. That was 2003. Twenty years later, after 20 years of research, all of a sudden, they find out women who were in their 40s, 50s and 60s were starting to take estrogen for menopause and, guess what, the symptoms weren’t that bad. Actually, they were showing better quality-of-life type of things. Better sleep. The hot flashes were disappearing. So, (the FDA) said, “Maybe we need to re-look at the label and say things that we had on there 20 years ago or so are outdated.” So the black box came off. The adverse events that were life-threatening, they kind of put them more in fine print.
Q: Did the removal of the warning cause the increased demand for estrogen patches?
Marusiak: All of a sudden, word gets out that the label’s been changed. When that information came out, all of a sudden it just snowballed. Now, there’s this comfort factor. “Oh, we can get this. It’s no longer dangerous. So I’m going to get it. And I’m going to tell my sister, my aunts, everybody, to get our patches.” Now, there’s an over-prescription out there. You can just imagine people start panicking. They think, “There won’t be enough medication for me, and I need to get it now. I better get what my doctor ordered for me.” Well, the FDA really didn’t think about what happens on the manufacturing and supply chain side. They thought, “We’re doing this. There should be enough supply.” But we didn’t have the stock supply.
Q: What caused the supply shortage?
Schneller: From my perspective, (removing the black box warning) changed how clinicians prescribed. Number two, we’re getting an older population, and the demand has gone up significantly. I think it illustrates how dependent we are on global supply networks, because what goes into that patch comes from many places. The patch combines pharmaceutical ingredients and specialty materials. Also, there’s relatively little incentive to maintain (product) resilience and increase production. So it’s not a simple drug shortage. It’s a supply-and-demand shortage. Health care pays for efficiency, but rarely for preparedness.
Q: What can be done to address the shortage, and how long will that take?
Schneller: I think you could have regulatory flexibility during shortage in terms of incentivizing companies (to produce more product). You can obviously give financial incentives, whether that comes from the government or the pharmaceutical manufacturers. I think with some incentives this could be fixed fairly quickly.
Q: What advice would you give women who need the estrogen patch but are unable to get it?
Marusiak: I would say one thing: You’re not alone. There are many other women in the same situation. The best thing is to be proactive. Talk to your clinician. Don’t be afraid and don’t ration your medicine. Be an advocate for yourself. And then, think a couple of weeks ahead. Don’t wait until your supply is out. Reach out to your clinician and, if you can’t get the patch, find out what your backup plan is.
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