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Jump to Key Points Sept 3 (Reuters) - The U.S. health regulator said on Thursday it is working with all six manufacturers to increase the supply of estradiol transdermal patches, used to treat menopause symptoms, after reports of patients having difficulty in readily accessing them.
A surge in demand for estrogen patches has strained supplies and led to shortages.
While the U.S. Food and Drug Administration has not designated the patches as being in shortage, women have been pharmacy-hopping in their search, reducing or switching dosages and changing brands or types of therapy.
Estradiol transdermal patches, which deliver the estrogen hormone directly into the bloodstream, are used to ease menopause symptoms such as mood swings, hot flashes and sleep disturbances.
- FDA working w/ 6 manufacturers to ↑ estradiol patch supply.
- Demand surge tied to menopause symptom treatment after boxed-warning removal.
- Access issues reported: pharmacy-hopping, dose reductions, brand/therapy switching.
- FDA says patches remain available; availability varies by pharmacy/location.
- Manufacturers expanding shifts, capacity, batch sizes; some shortages persist.
More than 1 million U.S. women begin menopause each year. Demand for these products increased after the FDA removed the long-standing "boxed warning" that highlighted risks such as cardiovascular disease, breast cancer and probable dementia.
The regulator said although availability of certain products or brands may vary by pharmacy or location, estradiol transdermal patches remain available.
The FDA did not list the names of the manufacturers.
Companies such as Amneal, Sandoz, Noven, Bayer, Zydus and Viatris sell estradiol patches in the US.
Hormone Replacement Therapy patches are complex to manufacture and expanding capacity is difficult, a Sandoz spokesperson said, adding the company has allocated additional supplies for women in the U.S. to meet rising demand.
Bayer in a statement said it expects to experience temporary supply constraints affecting one Climara estradiol patch dose until early 2027.
Viatris told Reuters estradiol patches require specialized equipment that is slow to scale, and that it is adding a production line and seeking third-party partners to boost supply.
The other companies did not immediately respond to Reuters requests for comment.
Data from the American Society of Health-System Pharmacists show that patches from Sandoz, Viatris, Noven and Zydus are in shortage.
The FDA said the companies are increasing production, adding manufacturing shifts, expanding production capacity, increasing batch sizes, adding specialized equipment and manufacturing lines as well as prioritizing production of the patches.
The regulator is monitoring supply and offering assistance to manufacturers seeking to increase production, including expediting the review of submissions related to increasing supply when appropriate.
(Reporting by Sriparna Roy and Christy Santhosh in Bengaluru; Editing by Shreya Biswas and Shailesh Kuber)
