Hormone therapies for menopause will no longer carry a black box warning about serious risks such as breast cancer, heart attack and stroke, the Food and Drug Administration announced Monday.
In the announcement and an accompanying editorial in the medical journal JAMA, FDA Commissioner Marty Makary and other agency officials said the warnings are based on outdated science and have discouraged women from taking hormone therapy.
The medications are commonly prescribed to treat menopause symptoms such as hot flashes, mood swings, difficulty sleeping, urinary tract infections, bone fractures and vaginal dryness. They replace estrogen and progesterone — hormones that decline during menopause — and come in the form of pills, patches, gels and creams.
“We are going to stop the fear machine steering women away from this life-changing, even lifesaving, treatment,” Makary said in a news conference. “The FDA is taking action to remove the black box warnings from estrogen-related products. This is based on a robust review of the latest scientific evidence.”
In the JAMA editorial, Makary and three other FDA officials wrote that the warnings — which appear on medication packaging — will be removed from products that contain estrogen or progestogen only, as well as the two combined.
“With the exception of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women on a population level more than hormone therapy,” they wrote.
Many doctors have similarly argued that the warnings are unnecessary and that the benefits of the medications outweigh potential risks.
“Our big concern about the black box warning is that a lot of women are excited about walking out the office and then go home and read the black box and then never start it, because they get scared,” said Dr. MargEva Cole, an obstetrician-gynecologist at Duke University School of Medicine.
The warnings were a response to a 2002 clinical trial that was halted after it detected an increased risk of breast cancer, heart attack and stroke in women receiving hormone therapy. The trial looked at a particular formulation of progesterone that is not commonly used today. Doctors say it was also biased toward women in their 60s and 70s, whereas women typically start hormone therapy in their 40s or 50s.
Hormone therapy prescriptions decreased after the trial was halted.
Studies done more recently have not found the same increased risk of adverse events with the current formulations of hormone therapy.
The FDA said Monday that it is adding a recommendation on the labels of hormone therapy to start the treatment in women younger than age 60 or within 10 years of the onset of menopause (when symptoms are usually most pronounced).
Information about a risk of adverse events will still appear on the package inserts, the FDA said.
The FDA also announced that it is approving two new drugs to treat menopause symptoms: a generic mixture of estrogen hormones and a nonhormonal treatment for moderate to severe hot flashes.
In July, the agency convened a panel of experts who were pro-hormone replacement therapy. During the panel, Makary highlighted the potential for the treatment to reduce cognitive decline and the risk of Alzheimer’s, though more research is needed.
Beaux Abington, a 51-year-old in Florida, said she is among the women who have struggled to obtain hormone therapy. Her mood suddenly started to sour when she turned 48, she said, and she suspected it was due to perimenopause. But Abington said three doctors declined to treat her with hormone therapy before she was eventually prescribed it at an anti-aging clinic.
“I was not in a good place. I couldn’t get out of bed,” she said.
After receiving the medication, Abington said, her mood started to improve: “It just was like all of the parts of my brain coming alive again.”
