Long Island women scramble for hormone replacement therapy as demand surges

Jeanette Cincotta, 44, of Greenport, relies on a weekly hormone patch to ease the night sweats, sleeplessness and anxiety that began after she underwent a hysterectomy a year ago.

The medication provided immediate relief. "I felt like myself again," she said.

But getting that medication renewed regularly has been a challenge.

Last month, Cincotta visited her pharmacy only to hear her patches for menopausal hormone therapy — often referred to as hormone replacement therapy, or HRT — in the doses she needed were unavailable.

"The pharmacist actually turned the computer screen around and showed me everything that he couldn't get was just highlighted in red," she said.

She’s not alone. Women across Long Island and the United States are continuing to have trouble filling their prescriptions for hormone patches, according to doctors, pharmacists and other experts. And it could get worse.

Dr. Megan Lochner, an obstetrician-gynecologist at Stony Brook Medicine, said she has received frantic calls from patients unable to refill their patch prescriptions.

"They are calling my emergency service after hours, freaking out, because they remember what it felt like before they were on the hormone therapy and they don't want to go back there," she said.

In November, the U.S. Food and Drug Administration asked manufacturers to remove the "black box" warning label on menopausal hormone therapy linking it to risks of cardiovascular disease, breast cancer and probable dementia.

Women also are speaking more publicly about their quest to find relief from hot flashes, brain fog, vaginal dryness and sleeplessness that often come with the onset of perimenopause and menopause.

The surge in demand, coupled with a limited number of companies manufacturing the patches, has contributed to shortages, experts said.

About 20 types of transdermal estradiol patches, containing a synthetic hormone similar to the one made naturally in women’s bodies, were in shortage as of July 1, according to the American Society of Health-System Pharmacists website.

"We really started to hear complaints about the shortage toward the end of January," said Erin Fox, associate chief pharmacy officer at the University of Utah Health. She works with a team that researches drug shortages and provides updated data to the ASHP's website.

"When we started following it in January and February, there were 10 or 11 specific strengths and products that were short," she said. "In our latest update, we have 20."

While the FDA does not classify estradiol patches as being in a shortage, a spokesperson in a statement said increased demand "has affected its availability" and the agency has offered assistance to manufacturers to increase supply.

Cincotta scoured pharmacies around Long Island but was not able to find the patches she needed, which have a lower dose of estrogen. Her hysterectomy was due to endometriosis, a painful condition in which tissue grows outside the uterus. A high dose of estrogen could trigger a return.

"I panicked at the thought of going back to where I was right after surgery and feeling like I couldn't get out of bed," she said.

After discussions with her gynecologist, she went with a patch that had a higher dose of hormones — a situation she hopes is temporary.

"I'll take whatever I can get at this point," she said.

Hormone treatments for women in perimenopause or menopause come in several doses and forms including pills, gels, creams and patches.

"They will all equally help with the symptoms," said Dr. Erika Banks, chair of obstetrics and gynecology at NYU Langone Hospital-Long Island. Patches are sometimes preferred, she said, because there can be a lower clotting risk, and they "theoretically" can provide a steadier hormone level.

Most women between ages 45 and 55 enter menopause, the stage of life where they no longer have menstrual periods and they produce less estrogen. Estrogen hormones are responsible for sexual and reproductive development, as well as bone and heart health, mood and other important functions of a woman's body.

These changes can cause symptoms such as hot flashes, night sweats, irritability and loss of bone mass, increasing the risk of osteoporosis.

Some women will experience these symptoms years earlier, during perimenopause, when hormone levels fluctuate and periods become irregular.

Switches in policy

The earliest forms of hormone replacement therapy started in the late 1800s and continued through the 20th century. Popularity soared in the 1960s and 1970s as women, doctors and drug companies embraced using hormones to ease physical and emotional symptoms associated with menopause.

Concerns about an increased risk of cancer and blood clots slowed interest in HRT for a time in the late 1970s, only to emerge again over the next two decades.

"It's a pendulum and it swings back and forth. There was a time period where women were all told to be on hormone replacement therapy, and it was the answer to everything," said Banks, the doctor at NYU Langone.

In the late 1990s, a large research initiative began tracking 16,608 postmenopausal women between ages 50 and 79 to assess the health benefits and risks of menopause hormone treatment. In 2002, the authors of the Women's Health Initiative found the risks for breast cancer, coronary heart disease and blood clots outweighed the benefits. Many doctors stopped recommending hormone replacement. Women were afraid to take it, and the FDA ordered the warnings on boxes.

In recent years, researchers found the study had limitations, said Lochner, who specializes in hormone therapy, as well as nonhormonal treatments for the symptoms of perimenopause and menopause.

"We've been asking for this warning to be removed for over a decade," she said. "You can't apply the findings [in] a 70-year-old to a 45-year-old who can't sleep, has night sweats, is agitated all the time."

She said many women were taken off their hormone therapy "as a direct result of this flawed study."

Banks noted the study did not focus on 49- to 51-year-old women with incapacitating hot flashes — a key demographic for menopausal hormone therapy. Instead, the study looked at a broad age group.

"The Women's Health Initiative study came out and scared a lot of patients and providers, probably unnecessarily," she said. "Now the pendulum is swinging back."

Both Banks and Lochner said doctors and patients should have a discussion about risks and benefits before starting hormone therapy.

"If somebody has had three heart attacks and open heart surgery, then that would be a very different conversation than somebody who is very healthy and exercises regularly and has a good cholesterol and those types of things," Banks said.