FDA removes safety warnings on 23 hormone products as menopause treatment demand rises

Women managing menopause symptoms now have updated federal guidance and new medical advice to guide their care. On Friday, federal officials confirmed that the Food and Drug Administration is taking steps to ensure an adequate supply of hormone therapies. This follows the agency's decision to remove federal safety warnings from these products, a move that has increased patient interest.

The American College of Obstetricians & Gynecologists released new advice this month. The group stated that moderate to severe or bothersome menopausal symptoms should be treated with hormone therapy as the first line of treatment. Dr. JoAnn Manson, a professor of medicine at Harvard Medical School, noted that while the therapy is not appropriate for all women, it is a good option for many.

Menopause is defined as the time when a woman has gone 12 consecutive months without a menstrual period. In the United States, this usually occurs around age 50. ACOG reports that more than half of women in menopause experience vasomotor issues such as hot flashes and night sweats. As many as two-thirds report sleep disruption, and more than a third of perimenopausal and postmenopausal women worldwide report depressive symptoms.

For over 22 years, all hormone-based menopause treatments carried a government warning. This warning followed a 2002 study that linked a pill-based combination of estrogen and progestin to breast cancer, blood clots, and other serious issues. Last year, the FDA announced it would remove the boxed warning from more than 20 pills, patches, and creams containing estrogen and progestin. On Friday, the FDA approved updated labeling for three additional estrogen-based patches.

Some women have reported difficulty obtaining estrogen patches in certain doses and formulations since the labeling change. However, FDA officials said they are unaware of an imminent risk of a nationwide shortage. They noted that drug manufacturers have doubled their output of these products over the last year by adding extra manufacturing shifts and production capacity.

Dr. Camille Clare, the president of ACOG, said the group would love for patients to go to their OB-GYNs and advocate for getting the treatment they need. The guidelines recommend that decisions about hormone therapy be made jointly by doctors and patients. The group advises starting treatment before age 60 or within 10 years of menopause if appropriate.

For patients who choose not to take full-body hormonal medications, doctors pointed to other options. These include fezolinetant and elinzanetant, which work in the brain to block sources of hot flashes. Certain antidepressants can also help manage symptoms. ACOG said there is evidence supporting non-drug treatments such as cognitive behavioral therapy, mindfulness, exercise, clinical hypnosis, and acupuncture.

Dr. Stephanie Faubion, medical director at The Menopause Society, said it is undisputed that hormone therapy is the most effective treatment for hot flashes. She added that women have lots of options, hormonal and nonhormonal, and should not be told that nothing can be done about their symptoms.