FDA Removes Warnings on Hormone Therapy; Experts Raise Concerns

The US Food and Drug Administration (FDA) has announced the removal of broad black-box warnings on estrogen-related medications for menopause, a decision that has sparked significant debate among healthcare professionals. This announcement, made by FDA Commissioner Marty Makary, bypassed the agency’s usual regulatory protocols and has been criticized by experts who argue that it exaggerates the scientific consensus surrounding these treatments.

The FDA’s action eliminates a warning that has been in place since 2003, which cautioned against the risks of cardiovascular disease, breast cancer, and dementia associated with hormone therapy. While experts agree that local vaginal estrogen products can be beneficial, they express concern regarding systemic estrogen therapies, which present a more complex risk profile.

Hormone therapy is known to alleviate menopause symptoms such as hot flashes, insomnia, and joint pain. However, health officials, including Robert F. Kennedy Jr., Secretary of the US Department of Health and Human Services (HHS), have suggested that hormone therapy may also prevent serious health issues like heart disease, osteoporosis, and even extend life expectancy by as much as 10 years. Makary characterized the removal of the warnings as a “medical breakthrough,” stating, “There may be no other medication in the modern era that can improve the health outcomes of women on a population level than hormone replacement therapy.”

Despite these claims, many researchers caution that there is no substantial evidence to support the assertion that hormone therapy benefits all menopausal women. Lauren Streicher, a clinical professor of obstetrics and gynecology at Northwestern University, stated, “To make that blanket statement that every woman should take this to prevent heart disease – it’s not true.” She emphasized that the FDA’s decision sends a “harmful” message to women seeking reliable information about their health.

Concerns about the scientific integrity of the decision were echoed by Pauline Maki, a professor at the University of Illinois. Maki highlighted the confusion this might cause, stating, “Women are trying desperately to get the truth, and they’re having a really difficult time.” Furthermore, she noted that research in her area of expertise—dementia—does not support the use of hormone therapy as a preventive measure.

An HHS spokesperson cited randomized studies indicating that women who initiate hormone replacement therapy (HRT) within ten years of menopause onset may see reduced mortality rates. However, the HHS did not provide clarification on the claims regarding protection against dementia or the broader implications of hormone therapy for all menopausal women.

This decision marks a departure from traditional FDA practices, as it relied on a roundtable panel that did not allow for public comments prior to the discussions, according to reports. Streicher, who had initially planned to participate in the panel, withdrew after concluding that the discussions were not scientifically rigorous. “It became very clear to me that this was not going to be a scientific panel,” she said, expressing concern over the potential ramifications of the FDA’s approach.

The FDA’s new strategy was defended by Makary, who described the typical advisory committee process as “bureaucratic, long, often conflicted and very expensive.” He indicated that future panels would feature participants who are encouraged to express their views passionately, which he believes is necessary for advancing public health.

The evidence surrounding hormone therapy is multifaceted, particularly when distinguishing between local and systemic applications. Local vaginal estrogen products, such as creams and tablets, are generally deemed safe and effective for treating specific symptoms. In contrast, systemic estrogen carries risks, including an increased likelihood of blood clots and potential links to breast cancer when synthetic progesterone is involved. Streicher emphasized the need for careful, product-specific labeling rather than broad categorizations.

Maki, who once believed that estrogen loss during menopause could impair memory, has shifted her perspective following her own research. Large randomized trials showed no benefits from hormone therapy for cognitive function, and in some cases, a trend toward harm was observed. She now believes that managing menopause symptoms—whether through hormone therapy or alternative treatments—is crucial for cognitive health.

Despite the claims made by health officials, Maki criticized their reliance on selective data from smaller studies while disregarding more comprehensive randomized trials. The FDA’s decision has sparked discussions about the need for a more balanced and evidence-based approach to hormone therapy regulations.

As the implications of this decision unfold, the medical community continues to grapple with the complexities of menopause treatment. While hormone therapy may provide significant benefits for women experiencing severe symptoms, the argument for its widespread use as a preventative measure remains contentious. “Hormone therapy is safe and effective for those with menopause symptoms,” Streicher concluded, “but do I tell every single woman who goes through menopause that she needs to be on hormone therapy? Absolutely not.”