Menopause hormone therapy is in short supply at some pharmacies : NPR

The use of hormone therapy to treat menopausal symptoms has seen steady growth in recent years, due to evolving safety evidence and new delivery methods.

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With the removal of the black box warning on menopause hormone therapy, some providers and patients are reporting shortages or delays, waiting for a pharmacy to restock transdermal estrogen patches.

When Jennifer Skoog Mondesir went to the pharmacy to pick up her estrogen patch, she never knew what she would find.

Mondesir, who is in her 40s and perimenopause, relies on the patch to help improve symptoms, including lack of energy. She lives in Jersey City, New Jersey. But last summer, she started hitting a frustrating wall.

“I’ve been to CVS. I can’t tell you how many times I’ve gone there and they’re like, ‘We’re out of patches,'” she says. Or they would tell him to come back tomorrow. “So it was like a crazy monthly hustle,” Mondesir says.

Mondesir is not alone. Doctors who prescribe hormone therapy to manage menopausal symptoms report constant shortages and delays, which are partly due to growing demand. This is a reversal from the early 2000s, when the treatment fell out of favor.

Dr. Nora Lansen, chief medical officer of Elektra Health, says the use of hormone therapy has increased steadily in recent years as clinicians and patients have taken a new look at the evidence.

“Over the past four or five years, demand has increased as clinicians have become more familiar with the research being done and patients have become more interested,” Lansen said.

This change represents a turnaround from the early 2000s, when the use of hormone therapy plummeted. At the time, the Food and Drug Administration placed a black box warning — the strictest safety label — on estrogen products, following the results of the large Women’s Health Initiative study. It found that women on hormone therapy faced increased risks of heart attack, stroke and pulmonary embolism, “which of course raised serious concerns among users and prescribers,” Lansen said.

Last year, the FDA removed this black box warning, highlighting evolving safety evidence, new methods of delivering hormone therapy, and alternative product combinations.

A key change is how estrogen is delivered. As an alternative to oral estrogen pills, which 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 an initial pass through the liver. Lansen says the distinction is important.

“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 going through the liver and its metabolism, this transdermal version of estradiol is actually a much safer option. And that’s why there is such a demand,” she says.

CVS, in a statement to NPR, confirmed that manufacturers were unable to supply enough estrogen products. The American Society of Health-System Pharmacists lists several estrogen products with current or recent shortages, but 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 honoring its current contracts and working to increase production to meet growing demand, the release said.

For Mondesir, a personal trainer, the stakes seemed high. Before starting hormone therapy, fatigue was a daily struggle.

“I have to show up to my clients with energy. And I discovered that I would have to have a second, a third cup of coffee, which is not like me,” she says.

After switching to an online pharmacy, she was able to fill her prescription without interruption or delay.

“My energy level is much better,” she says. And she hopes that as supply and demand balance, the shortages and delays will stop.