Estrogen patches harder to find as FDA pushes hormone therapy

Estrogen patches, one of the most common forms of hormone therapy for women, are becoming harder to find, and some manufacturers say a recent action by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is a significant driver of rising demand.    

In November, Kennedy announced from HHS headquarters that the Food and Drug Administration (FDA) was lifting the black box warning from hormone replacement therapy products for menopause, which had warned of the treatment’s potential to accelerate preexisting breast cancers in a woman’s body. 

While the FDA’s drug shortage list does not currently list estrogen patches as being in shortage, manufacturers and physicians say demand has risen in response to the black box removal, in some cases beyond what they can supply. 

“Over the last month especially, it’s been harder to get the transdermal patches, especially at the more common doses,” Monica Christmas, director of the Center for Women’s Integrated Health at the University of Chicago and associate medical director for the Menopause Society, told The Hill. 

While transdermal patches have become harder to get, Christmas said she has been pivoting her patients to the various other forms of estrogen that are on the market. 

Those alternatives include topically applied products like gels and sprays, as well as pills, vaginal rings and vaginally administered estrogen therapy.

Christmas emphasized that while patients might struggle to find patches at the moment, estrogen hormone therapy is not in shortage more broadly. 

In her practice, Christmas said she hasn’t changed how she approaches hormone therapy following the removal of the black box warning, adding she has not personally seen more patients coming and asking for it.

Manufacturers confirmed to The Hill they are seeing a jump in demand, with some attributing it to the removal of the black box warning. 

“We fully recognize the unique and often challenging needs of women going through peri‑ and menopause, and we take the current supply situation for hormone replacement therapy (HRT) transdermal patches very seriously,” Sandoz, one of the main manufacturers of estrogen patches, said in a statement to The Hill.  

“Recent changes in prescribing behavior due to the FDA’s removal of boxed warnings on HRT patches have created an unprecedented demand that cannot be fully met at present,” the company added. “We know this situation is frustrating and inconvenient for the women who rely on these patches.”  

Other manufacturers say they’re currently able to meet heightened demand and are working to maintain supply. 

“We are meeting our current supply plans. In addition, we know demand for this product has increased and we are currently taking steps to optimize current capacity and further expand production long-term,” pharmaceutical company Viatris said in a statement. 

The decision to take the black box warning off hormone therapy for menopause was welcomed by several women’s health organizations, including the Menopause Society, which backed the move with some caveats. 

“Systemic estrogen still comes with potential risks that should be reviewed in detail with women initiating therapy,” the organization said at the time. “The risks are low for younger, healthy women initiating hormone therapy closer to the menopause transition. Risks are greater when initiated in older women and in those who are further from menopause onset.” 

HHS spokesperson Andrew Nixon told The Hill that all five producers of estrogen patches are manufacturing at full capacity. Along with Sandoz and Viatris, the other patch manufacturers are Amneal, Noven and Zydus.

“We are working with all of the manufacturers on ensuring that supplies meet demand and will continue to offer our assistance on anything they need to increase supply,” said Nixon. 

“Currently, it is not in shortage. We continue to monitor supply and are offering our assistance to the manufacturers with anything needed to increase supply.” 

According to Christmas, while the removal of the black box warning may have sparked some renewed interest in hormone therapy, the high demand for transdermal patches has been going for years. She said the announcement in November only compounded a preexisting trend, which has been referred to as the “menopause gold rush” by some in her field.  

As countries’ populations around the world grow older, the menopause and perimenopause market is expected to boom. According to data from Grand View Research, the global menopause market is expected to hit $24.35 billion by 2030. 

“This has become lucrative in a way that many people are trying to cash in on, and that isn’t always a good thing for women,” said Christmas. “It’s not just for hormone therapy, but it’s for all kinds of things; lotion, potions and the like.” 

Online companies promising “convenient” same-day prescriptions for estrogen patches have also proliferated online with the rise of telemedicine platforms. Companies like Sesame, Winona and Evernow offer quick and easy access to estradiol patches. 

While all three companies offer multiple different versions of estrogen therapy, Christmas lamented that many sellers only offer the patch as it’s an affordable option and is an easier treatment to train midlevel providers on. 

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