US Estrogen Shortage Expands to Creams and Injections as Demand Soars

A nationwide shortage of estrogen hormone replacement therapies in the United States has intensified, expanding beyond the widely reported scarcity of transdermal patches to now include injectable solutions and vaginal creams. The widening supply crunch is being fueled by a significant surge in patient demand, forcing women and their healthcare providers to navigate an increasingly limited set of treatment options for menopause symptoms.

Shortages Spread to Alternative Treatments

While the U.S. Food and Drug Administration (FDA) has been working with manufacturers since September to address the patch shortages, other forms of the hormone are now also in short supply. The American Society of Health-System Pharmacists (ASHP) listed multiple estradiol products as being on backorder or in short supply as of early September.

According to the ASHP, affected products include:

• Estradiol injections from manufacturers such as Hikma, American Regent, and Par Sterile Products.
• Vaginal estradiol creams made by Viatris' Mylan unit, Padagis, and Teva.

Dr. Kathleen Jordan, chief medical officer of telehealth provider Midi Health, told Reuters that a "domino effect" is occurring. "Persistent patch shortages have been going on for a while and as prescribers and their patients go to alternative gels and creams, there has been a domino effect impacting the supplies of these prescriptions as well," she said.

Unprecedented Demand Fuels Scarcity

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The primary driver of the shortages is a sharp increase in demand for hormone replacement therapy. This follows the FDA's removal last year of a long-standing "boxed warning" on some hormone treatments that had signaled potential health risks found in a large 2002 study.

In September, the FDA stated that the U.S. supply of approved estradiol patches had nearly doubled over the previous year but still had not kept up with demand. Illustrating the scale of the demand, billionaire entrepreneur Mark Cuban said his Cost Plus Drugs online pharmacy had seen demand for its products surge fivefold to tenfold.

Manufacturers Scramble to Boost Production

Pharmaceutical companies are now working to increase output to meet the elevated demand. Viatris (VTRS), a manufacturer of both patches and creams, acknowledged a "significant surge in demand" and said it had moved its St. Albans, Vermont, facility to around-the-clock production. The company stated it is also investing in new equipment and a new production line to expand long-term capacity.

Similarly, Amneal (AMRX), another patch manufacturer, confirmed that demand increased significantly after the FDA's warning removal and that it was working to increase production. However, pharmacy chains like CVS Health (CVS) confirmed that manufacturers have struggled to provide sufficient supplies of estradiol injections, a situation it said has worsened in recent weeks. Teva, Padagis, Hikma, American Regent, and Par Health did not respond to Reuters' requests for comment.