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.
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.
Some of the main pharmaceutical companies producing estradiol transdermal patches sold in the U.S. include Amneal, Sandoz, Noven, Zydus and Viatris. The companies did not immediately respond to Reuters’ request 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 in Bengaluru; Editing by Shreya Biswas)
