The Food and Drug Administration announced that it’s removing the black box warning on hormone replacement therapy medications for menopause. The announcement comes “after more than two decades of fear and misinformation surrounding hormone replacement therapy (HRT),” the agency said in a press release. In addition to improving women’s health, the change could also help women thrive in their careers.
A black box warning is the FDA’s strongest caution and alerts doctors and patients to serious or life-threatening risks associated with a medication. The warnings were added to the HRT medications in 2002, after the landmark Women’s Health Initiative (WHI) study reported an increase in the risk of breast cancer, heart disease, and stroke among women taking combined estrogen-progestin therapy. The findings caused widespread alarm and led millions of women to stop hormone treatment. But later analysis revealed serious limitations to the study methods. For example, the average participant was 63 years old, more than 10 years past the average age when most women begin menopause. Also, the formulation and dosage of estrogen used were not the ones typically prescribed today.
More recent research reveals that the benefits of HRT outweigh risks for most women who start before age 60. “Randomized studies show that women who initiate HRT within 10 years of the onset of menopause (generally before age 60) have a reduction in all-cause mortality and fractures,” the FDA reports. They cite studies indicating that women taking HRT reduce their risk of cardiovascular diseases by as much as 50%, Alzheimer’s disease by 35%, and bone fractures by 50 to 60%.
Nonetheless, the black box warnings left many women afraid to take hormone therapy, and left some doctors reluctant to prescribe it. Maura Quinlan, a gynecologist and clinical faculty member at Northwestern University who practices at PCC Wellness in Chicago, says that she’s seen that fear firsthand. “In my experience, after we talk about her specific symptoms and history, and my patient has come to the conclusion that HRT will be helpful to treat her symptoms, the prominent black box warning on the medication packaging can cause new worry. Worry that is not based on science,” Quinlan says.
Indeed, research indicates that the warnings keep women from taking HRT. One 2020 JAMA study of over 13,000 menopausal women found that less than 5% were currently taking hormone therapy, down from 27% prior to the WHI study. In addition, a 2019 Mayo Clinic study revealed that about one-third of obstetrics and gynecology residents said they wouldn’t offer hormone replacement therapy to a symptomatic, newly menopausal woman, despite evidence that it could dramatically improve her quality of life.
Menopause Symptoms May Impact Careers
In addition to impacting overall well-being, several studies and surveys reveal how menopause symptoms can impact women’s careers. In a September survey of 900 postmenopausal women by resume-building site LiveCareer, nearly one-third said they had considered switching jobs, changing roles, or reducing their hours because of menopause symptoms. In addition, 97% of the women surveyed said they felt pressure to hide or downplay their menopause symptoms at work. Another study from the UK found that 12% of postmenopausal women have taken off from work at least one day due to their menopause symptoms.
Although there are dozens of symptoms associated with menopause, hot flashes are among the most common. Quinlan explains, “Hot flashes wake you up several times every night, and several times during every day you are randomly dripping sweat. So, understandably, you may be distracted and your work can suffer.” She knows firsthand what that’s like; she’s experienced it herself and now takes HRT. Among her patients, the intensity of their symptoms varies, as does the toll on their careers. “It’s just hard to be your best when you are tired and cranky,” she adds.
Carol Tavris, coauthor of Estrogen Matters, compares menopause symptoms to a weight that women must carry in the workplace. “The removal of the black box warning is not only a huge step forward for women’s health and well-being, but also for their financial and professional success. Women still have to fight to get into the upper echelons of the workplace with men, and then, when menopause hits, too many women find themselves competing with men with a one-ton weight on their backs: the symptoms that the majority of them experience when their estrogen is depleted,” Tavris wrote via e-mail.
Menopause often arrives just as women are stepping into their peak career years and taking on leadership roles. Tavris says that removing the warnings will help lift the weight for some women and begin to level the playing field at work.
Ultimately, the choice of whether to take HRT to relieve menopause symptoms is a personal one. It depends on personal preferences, medical history and symptom severity. Adding to women’s choices, the FDA also announced the approval of two new drugs aimed at expanding treatment options for menopausal symptoms, including a non-hormonal therapy for hot flashes. The more options women have, the better equipped they’ll be to protect both their health and their careers.