US FDA is working with manufacturers to boost estradiol patch supply amid access concerns
XLV•FDA works with manufacturers to increase supply
The U.S. health regulator said on Thursday it is working with all six manufacturers to increase the supply of estradiol transdermal patches after reports of patients having difficulty in readily accessing them.
A surge in demand for estrogen patches to ease menopause symptoms such as mood swings, hot flashes and sleep disturbances 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.
Availability remains uneven by pharmacy and location
The estradiol transdermal patch delivers the estrogen hormone directly into the bloodstream to treat menopause symptoms.
The regulator said although availability of certain products or brands may vary by pharmacy or location, estradiol transdermal patches remain available.
It is monitoring supply and offering assistance to manufacturers seeking to increase production, including expediting the review of submissions related to increasing supply when appropriate.
