By Mrinalika Roy and Sriparna Roy
April 9 (Reuters) - A surge in demand since last year for estrogen patches to ease menopause symptoms has strained supplies and led to shortages, sparking a scramble for medicines that industry sources say could last up to three years.
More than 1 million U.S. women begin menopause each year. Over the past two years they have increasingly sought out estrogen patches to treat mood swings, hot flashes and sleep disturbances. Social media in particular has been a forum
for changing views on the medicines' safety and benefits.
The U.S. FDA began publicly extolling hormone replacement therapy as "lifesaving" last July, and in November it removed a longstanding safety warning from the therapies. The change in the Food and Drug Administration's stance was followed by a 26% jump in patch use through February, according to data from health data and analytics company Truveta.
"When the FDA removed the safety warning in November, it created unprecedented demand that cannot fully be met at present," said a spokesperson for Swiss generics manufacturer Sandoz, which has shipped additional supplies to the U.S. to help ease shortages.
The patches are a type of hormone replacement therapy that delivers estrogen directly through the skin into the bloodstream.
"For 20 years, less than 5% of women took hormone therapy. Now those numbers are growing... and scaling up production of medications is not as easy as it might seem," said Dr. Gillian Goddard, adjunct assistant professor at the NYU Grossman School of Medicine.
While the FDA has not designated the patches as being in shortage, women are pharmacy-hopping in search of them, reducing or switching dosages and changing brands or types of therapy, according to interviews with six patients, three telehealth companies, and six industry experts.
Abruptly stopping use can restart symptoms, while switching brands may bring new side effects, doctors said.
SEARCHING FOR SUPPLY
Amy Satterlund, 50, a product manager from Fort Pierce, Colorado, has been using the estrogen patch for about 18 months, but has recently struggled to find it.
She said she has had to plan for shortages at CVS pharmacies and long waits at online pharmacy Cost Plus Drugs.
"I do get nervous if I were unable to get my prescription refilled, that side effects or that the symptoms of perimenopause would come back," Satterlund said.
A CVS Health spokesperson said manufacturers have been unable to deliver sufficient quantities in recent weeks.
A Cost Plus spokesperson said it has added supply to keep up with exploding demand, but hasn't heard from its suppliers on shortages lasting for an extended period of time.
Andrew Nixon, a spokesman for the U.S. Health and Human Services Department, which oversees the FDA, said the agency is coordinating with companies to support efforts to boost the supply of patches.
CHANGING GUIDANCE, RISING DEMAND
FDA Commissioner Marty Makary last July turned the tables on previous cautions against HRT use. In interviews and postings, he said women had been advised against the treatments due to cancer risks, but that the scientific evidence has changed.
The 2002 Women's Health Initiative study had linked hormone therapy to increased risks for some cancers, dementia, heart attacks and stroke. Now, the American College of Obstetricians and Gynecologists on its website notes risks and benefits to the various types of HRT and advises patients who use them to talk with their doctor every year about whether to continue.
Using its electronic health record database covering more than 130 million patients in all 50 states, Truveta found use of most forms of HRT has climbed in recent years, with the sharpest increase a 184% jump in estrogen patches since 2023. Vaginal cream HRT use rose 122% over the same period.
By February 2026, about 5 out of 100 women aged 45-54 had been prescribed estrogen-based HRT, roughly doubling since 2023, based on an analysis of women who had received any medical prescription during that period.
Telehealth platform HRT Club, which helps patients access hormone therapies and physicians, said patch sales had risen 150% since the FDA's November actions.
MANUFACTURING BARRIERS
Estrogen patches are generic medicines with low profit margins, providing manufacturers few incentives to invest quickly in new production lines or facilities that can take years to build.
Long-term contracts for supplies can also hinder manufacturers from quickly adjusting to demand changes, industry sources and doctors said.
Major makers of the patches, including Amneal, Zydus, Sandoz, Noven, and Viatris, all have some doses in shortage, according to the American Society of Health-System Pharmacists.
Amneal and Viatris said they were trying to boost patch supply to meet demand. Zydus and Noven did not respond to a request for comment.
Dr. Mary Rosser, an Ob-Gyn and director of Integrated Women's Health at Columbia University, said the FDA does have ways to mitigate shortages. These could include requiring manufacturers to have more diverse and back-up supply chains, and mandating minimum inventories and proactive inventory monitoring systems, she said.
The FDA declined to comment on such options.
"People have waited a long time to make a decision... about whether they want to use hormones," Rosser said. "Then they make the decision and then they can't get them."
(Reporting by Mrinalika Roy, Mariam Sunny, and Sriparna Roy in Bengaluru; Editing by Caroline Humer and Bill Berkrot)
