Surging demand for menopause patches prompts FDA action

FILE-A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)

Food and Drug Administration officials are collaborating with six manufacturers to boost the supply of patches designed to treat menopause symptoms amid an increase in demand for the patches and challenges obtaining them. 

Although the FDA hasn’t specified that the menopause patches are in short supply, Reuters reported that the women have searched pharmacies to find them, while lowering or switching dosages and changing brands or types of therapy.

The federal agency did not reveal the names of the manufacturers. 

Menopause patches in high demand

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Estradiol transdermal ​patches inject the estrogen hormone into the bloodstream and are used to ease menopause symptoms like mood swings, hot flashes and sleep disturbances.

According to Reuters, demand for the products surged after the Food and Drug Administration removed ​the "boxed warning" that emphasized risks, including cardiovascular disease, breast cancer and possible dementia.

RELATED: Menopause hormone therapy labeling changed under FDA

The FDA told Reuters that although availability of certain products or brands may vary by pharmacy or location, estradiol transdermal patches are still available.

Moreover, companies like Amneal, Sandoz, Noven, Bayer, Zydus and Viatris sell estradiol patches in the United States. 

Reuters spoke to some of these organizations regarding their capabilities to meet the consumer demand for the patches. 

A Sandoz spokesperson told Reuters that hormone replacement therapy patches are complicated to manufacture and widening ‌capacity is ⁠tough, and the company has set aside extra supplies for women in the U.S. to meet growing demand.

Bayer said in a statement, obtained by Reuters, that it expects to have temporary supply constraints impacting one Climara estradiol patch dose until early 2027.

Meanwhile, Viatris shared with Reuters that 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 Source: Information for this story was provided by Reuters, which cites comments and statements about the menopause patches from Sandoz, Bayer, and Viatris. This story was reported from Washington, D.C. 


 

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