With the removal of the black-box warning on hormone therapy for menopause, some providers and patients report shortages or delays, waiting for a pharmacy to restock transdermal estrogen patches.
When Jennifer Skoog Mondesir headed to the pharmacy to pick up her estrogen patch, she never knew what she'd find.
Mondesir, who is in her late 40s and in perimenopause, relies on the patch to help improve symptoms, including low energy. She lives in Jersey City, N.J. But last summer, she started running into a frustrating wall.
"I went to CVS. I can't tell you the amount of times I've been there and they're like, 'We're out of patches,'" she says. Or they'd tell her to check back tomorrow. "So it was like a monthly mad scramble," Mondesir says.
Mondesir is not alone. Doctors who prescribe hormone therapy to manage menopausal symptoms report rolling shortages and delays, which are, in part, due to rising demand. It's a reversal from the early 2000s, when the treatment fell sharply out of favor.
Dr. Nora Lansen, chief medical officer of Elektra Health, says use of hormone therapy has grown steadily over the past several years as both clinicians and patients have taken a fresh look at the evidence.
"Over the past four to five years, demand has picked up as clinicians have familiarized themselves with current research and patients have become more interested," Lansen said.
The shift is a turnaround from the early 2000s, when hormone therapy use plummeted. Back then, the Food and Drug Administration placed a black box warning — the strongest safety label — on estrogen products following results from the large Women's Health Initiative study. It found women on hormone therapy faced increased risks of heart attacks, strokes and pulmonary embolism, "which of course incited grave concern among users and prescribers," Lansen says.
Last year, the FDA removed that black box warning, pointing to evolving evidence of safety, newer methods of delivering hormone therapy and alternative combinations of products.
One key change is how estrogen is delivered. As an alternative to oral estrogen pills, which is what the women in the Women's Health Initiative study took, many women now use estrogen patches or gels, which deliver the hormone through the skin, bypassing a first pass through the liver. Lansen says that distinction matters.
"The transdermal version of estradiol has a lower risk of blood clots, and a blood clot can cause a heart attack [or] a stroke. So without passing through the liver and its metabolism, this transdermal version of estradiol is really a much safer option. And that's why there's been such demand," she says.
CVS, in a statement to NPR, confirmed that manufacturers have been unable to provide sufficient supplies of several estrogen products. The American Society of Health-System Pharmacists lists multiple estrogen products with current or recent shortages, but the manufacturers do not give a reason for the shortages.
A spokesperson for Amneal Pharmaceuticals, one of the companies that makes estradiol patches, wrote in a statement to NPR that "following the FDA's removal of boxed warnings on hormone replacement therapy, we have seen a significant increase in demand." The company is meeting its current contracts and is working to increase production to help meet growing demand, the statement said.
For Mondesir, a personal trainer, the stakes felt high. Before starting hormone therapy, fatigue was a daily battle.
"I have to show up to my clients with energy. And I found that I would have to have a second, third cup of coffee, which is not like me," she says.
After switching to an online pharmacy, she has been able to fill her prescription without disruptions or delays.
"My energy level is much better," she says. And she hopes as supply and demand even out, the shortages and delays will cease.
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