By Mrinalika Roy
Oct 28 (Reuters) – Women in the US struggling to find hormone replacement treatments to manage menopause symptoms are facing shortages beyond estrogen patches amid surging demand, with some injectable and vaginal estrogen products also in short supply.
The US Food and Drug Administration has been working with manufacturers since September to boost supplies of estrogen patches after months of shortages. But pharmacies and drug-shortage monitors are reporting problems with other forms of the hormone.
Demand for hormone replacement therapy has increased following the FDA’s removal last year of a long-standing boxed warning on some hormone therapy that had signalled possible heightened risk of breast and ovarian cancer, as well as strokes and other serious conditions found in a large 2002 study.
The new shortages may partly reflect women switching from patches that have become harder to find to alternative hormone therapy products, said Kevin Schipper, director of product lifecycle management at pharmaceutical consulting firm ProPharma.
The American Society of Health-System Pharmacists early in September listed multiple estradiol injection products from Hikma, American Regent and Par Sterile Products as being in shortage.
Separately, ASHP lists vaginal estradiol creams made by Viatris’ Mylan unit, Padagis, and Teva as being on backorder or allocation.
The FDA did not respond to a request for comment on the latest shortages.
SUPPLY-CHAIN ISSUES
CVS Health said manufacturers have struggled over the past several months to provide sufficient supplies of certain strengths of estradiol injections, a situation it said has worsened in recent weeks.
Dr. Kathleen Jordan, chief medical officer of telehealth provider Midi Health, described a growing number of supply-chain issues.
“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.
Cost Plus Drugs, the online pharmacy founded by billionaire entrepreneur Mark Cuban, said it was buying as much as possible from suppliers to maintain inventory levels. Cuban said demand for products sold through the platform had surged fivefold to tenfold “for almost every product” because of its low prices, while its suppliers were expanding capacity.
Cost Plus Drugs has been able to maintain estrogen replacement supplies with only intermittent interruptions, Cuban said in an email.
HIGH DEMAND
The FDA said in September that the US supply of FDA-approved estradiol patches had nearly doubled over the previous year but had not kept up with demand.
Viatris, one of several manufacturers of estradiol patches and creams, said it had seen a “significant surge in demand” and had been working throughout the year to increase supply. The company added a production shift at its St. Albans, Vermont, facility earlier this year, taking the plant to around-the-clock production, and said its output was now significantly higher.
“We are meeting our current supply plans for estradiol vaginal cream and are committed to supporting patient access to this needed treatment,” Viatris said.
The company added that it was investing in additional equipment and adding a new production line to expand long-term capacity. It is also pursuing potential partnerships with third parties to further increase the patch supply.
Amneal, another manufacturer of estradiol patches, said demand had increased significantly following the FDA’s warning removal and that it was working to increase production.
Teva, Padagis, Hikma, American Regent and Par Health did not respond to Reuters requests for comment.
ProPharma’s Schipper said the pattern of shortages did not appear to point to a broad lack of raw materials, although he cautioned that supply-chain problems could still be contributing to disruptions.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Caroline Humer and Bill Berkrot)
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