Could We Be Seeing the End of the Black Box Warning for Hormone Therapy Soon? Here’s What You Need to Know

Is the black box warning on vaginal estrogen warranted?

The conversation around hormone therapy has changed dramatically in recent years. For many individuals, especially women going through menopause or those seeking transgender healthcare, hormone therapy is vital.

However, concerns about its safety led the FDA to add a black box warning. Recently, rumors suggest that the FDA might consider lifting this warning.

Food and Drug Administration Commissioner Marty Makary, MD, convened a panel on July 17th aimed at "clarifying the facts" regarding the role of vaginal estrogen in easing menopause symptoms. While vaginal estrogen was the focus of the panel, experts couldn't help but discuss the overall data supporting the safety and efficacy of Menopause Hormone Therapy (MHT) and its general use.

The panel included a who's who of the "menopause community," such as Dr. Mary Jane Pinkerton, Dr. Rachel Rubin, and Dr. Vonda Wright, who considered the potential removal of the black box warning—the FDA's most severe warning—on vaginal estrogen products.

Hormone therapy has experienced a tumultuous history following the release of clinical trial data by the Women’s Health Initiative in 2002, which linked the treatment to a 29% increase in heart attacks, a 41% rise in strokes, and an elevated risk of breast cancer.

The trial was halted early, resulting in a significant decrease in the use of hormone therapy. In 2000, about 20% of women over 50 were using hormone therapy, as reported by the Menopause Society. In 2003, the FDA introduced a black box warning for estrogen products used in hormone therapy, and this figure dropped to under 5% by 2008

This warning remains in place today.

Despite the initial findings of the study being challenged, researchers later discovered significant flaws in the original research, such as involving women aged 65 and older who already had a higher risk of serious health issues, skewing the data, among other factors. Many women, as well as some doctors, have not accepted this. The original researchers also conducted a follow-up study published in JAMA in 2024, which clearly stated that the benefits of hormone therapy outweigh the risks for most healthy, symptomatic women.

Nevertheless, the black box warnings for estrogen persist.

Understanding the Black Box Warning

A black box warning is the most serious alert issued by the FDA, signaling that a drug carries a significant risk of severe or life-threatening side effects. This warning is designed to keep both healthcare providers and patients informed about potential dangers.

In hormone therapy, the black box warning primarily highlighted risks like breast cancer and cardiovascular issues. This warning came about due to mixed research findings that created confusion regarding menopause hormone therapy (MHT).

While the warning was intended to protect patients, it also sparked fear around the safety and benefits of hormone therapy, which may have prevented some individuals from seeking necessary treatment.

The Current Landscape of Hormone Therapy Research

Recent studies are changing how we view hormone therapy. Researchers are examining the safety of these treatments more closely, revealing complex results that support the effectiveness of MHT for specific groups.

For instance, research indicates that women who start hormone therapy around the time of menopause may have a reduced risk of osteoporosis and heart disease.

Studies show that timely MHT can decrease the occurrence of fractures by up to 40% in postmenopausal women.

With these findings, discussions about the black box warning are intensifying. The FDA's ongoing evaluation of hormone products reflects changing societal views on menopause, gender identity, and the importance of personal health choices.

Implications of Removing the Black Box Warning

If the FDA removes the black box warning, what could happen next?

Enhanced Access to Hormone Therapy

Removing the warning might encourage more patients to pursue hormone therapy without the fear that the label creates. Providers may feel more confident in prescribing MHT, resulting in improved care for many individuals. A 2023 study found that healthcare providers felt that the black box warning and lack of consensus in the use of MHT negatively impacted their willingness to prescribe hormone therapy.

Empowering Patient Choice

With the removal of the warning, patients may feel empowered to make informed decisions about their health. The absence of a cautionary label can create a more supportive atmosphere for discussing hormone therapy, allowing individuals to consider their options without stigma.

The Importance of Informed Discussions

Although a lifted warning could motivate more people to explore hormone therapy, having informed discussions with healthcare providers is crucial. Every patient is unique, and conversations should focus on the specific benefits and risks relevant to their health situation.

The Timeline for Potential Change

While we hope for a positive outcome, the FDA follows a careful process when considering regulatory changes. This involves thorough evaluations, input from various stakeholders, and comprehensive research analysis.

Reports indicate that discussions regarding the hormone therapy warning are ongoing, but any decisive action will take time. We may expect a formal announcement following detailed public discussions and assessments of new research findings.

Navigating the Transition: What Can Patients Do?

As we await updates from the FDA, patients can take steps to manage their hormone therapy journey:

1. Stay Informed: Follow the latest research and news related to hormone therapy. Being well-informed helps you understand your options more clearly. Your best source for this information is the Menopause Society. Menopause Talks is another excellent place for information!

   
   

2. Open Communication with Healthcare Providers: Maintain honest discussions with your healthcare team. Share your concerns, weigh potential benefits, and explore alternative treatments.

   
   

3. Advocate for Yourself: Always express your health needs. If you think hormone therapy is right for you, communicate that to your doctor and create a plan that includes regular check-ins. For tips on how to speak to your provider, you can download my free guide here.

   
   

4. Connect with Support Groups: Joining support groups can provide valuable insights and shared experiences from others on similar health journeys.

   
   

Looking Ahead: The Future of Hormone Therapy

The potential removal of the black box warning for hormone therapy is both hopeful and uncertain. While extensive discussions are still needed, any progress towards recognizing the complexities of hormone therapy is a positive step for patient empowerment and informed healthcare choices.

As we move forward, it is crucial to stay engaged, informed, and vocal about your health. Whether you are advocating for better understanding or waiting for policy changes, your health journey matters. With the correct information and connections, you can navigate these evolving circumstances with confidence.

In time, we may witness a significant transformation in the perception and prescription of hormone therapy. Regardless of the pace of change, the goal is clear: to promote transparent communication about treatment options and ultimately enhance health outcomes for many individuals.

To join the fight in refocusing the NIH (National Institutes of Health) to invest in menopause research, mid-life women’s health research, and finding new treatments for the symptoms of menopause, you can do so here.