What the Removal of Black Box Warnings Means for Women, Hormone Therapies, and Pharmacists

As perspectives on menopausal hormone therapy continue to evolve, pharmacists are playing an increasingly important role in helping patients navigate shifting evidence, updated safety guidance, and growing public interest. In this interview, Melinda Fowler, RPh, ABAAHP, FAAFM, founder of The Hormonal Pharmacist, shares her insights on the recent removal of long-standing FDA black box warnings and the subsequent shortages, how this change is influencing patient perceptions and demand, and the critical role pharmacists have in delivering individualized, evidence-based care. Drawing from more than 30 years of experience and a personal journey through midlife hormonal changes, Fowler highlights the importance of balancing clinical nuance with patient-centered communication in this rapidly changing area of practice.

This interview was lightly edited for clarity.

Pharmacy Times: Can you introduce yourself?

Melinda Fowler, RPh, ABAAHP, FAAFM: I’m Melinda Fowler, a pharmacist with over 30 years of experience and the founder of The Hormonal Pharmacist, a private consultative practice. I am also a fellow of the American Academy of Anti-Aging Medicine. I’ve spent most of my career in community pharmacy, where I saw how often we manage symptoms without addressing the root cause. That became personal when I went through my own midlife hormonal changes, which led me to explore functional medicine and take a more comprehensive, root-cause approach to care.

Today, I help women navigate perimenopause and menopause by combining traditional pharmacy with lifestyle modifications and bioidentical hormone replacement therapy. My focus is on individualized care, proper testing, and improving quality of life and enhancing longevity.

Pharmacy Times: The FDA recently removed long-standing black box warnings from menopausal hormone therapy products. From your perspective as a pharmacist, what prompted this shift in labeling? What misconceptions might you see in light of these changes?

Fowler: The change in labeling is long overdue and reflects a correction in how the Women’s Health Initiative (WHI) was originally interpreted and communicated. The WHI studied a very specific population: women who were older and often many years past menopause, using oral, synthetic [not bioidentical] hormone formulations. Those findings were then broadly applied to all women, regardless of age, timing, or hormone type, which created widespread and lasting fear around hormone therapy.

Over time, reanalyses of the WHI, along with additional research, have made it clear that those risks should not be universally applied. We now understand that timing of initiation of therapy, route of administration, formulation, and individual patient risk all significantly influence outcomes. As the evidence evolved, so did clinical guidance. Organizations like The Menopause Society (TMS) and American College of Obstetricians and Gynecologists (ACOG) began emphasizing a more individualized, risk-benefit approach, and the FDA’s updated labeling reflects that shift, moving away from a “one-size-fits-all” warning toward a more nuanced understanding of hormone therapy.

That being said, I do think we will still see misconceptions on both sides. Some may interpret this change as a blanket endorsement of hormone therapy without appropriate evaluation or monitoring. Others will remain anchored in outdated fear, continuing to avoid a therapy that could meaningfully improve quality of life for millions of women.

The reality is more balanced. Hormone therapy is neither inherently dangerous nor absolutely, universally appropriate. It is a clinical tool that requires context, thoughtful prescribing, and ongoing reassessment. This shift was not driven by a single moment or group; it was the result of evidence catching up with long-standing messaging and the medical community gradually realigning with what the data [have] been showing for years.

Pharmacy Times: How might the removal of these warnings influence patient perceptions of safety and willingness to initiate hormone therapy?

Fowler: For many women, the removal of the warning has been interpreted as confirmation that hormone therapy is now “safe,” which has increased willingness to initiate treatment. In some ways, this helps counter years of fear-based messaging, but it can also oversimplify a more nuanced clinical decision.

At the same time, there is still a significant group of patients who remain hesitant, largely due to the lasting impact of the original WHI messaging. For those women, the fear hasn’t caught up with the updated evidence. What we are seeing is a split response—some patients are moving toward hormone therapy more quickly, sometimes without fully understanding the importance of individualized assessment and monitoring. Others are still avoiding it altogether, despite being appropriate candidates.

This is where education becomes critical. The removal of the warning creates an opportunity, but it also places greater responsibility on clinicians to guide patients through a more balanced, evidence-based understanding. Hormone therapy isn’t a blanket “yes” or “no”—it is a decision that requires context, personalization, and ongoing evaluation.

Pharmacy Times: Following this update, are you already seeing increased demand or questions from patients about hormone therapies?

Fowler: Yes, without question. Since the update, there has been a noticeable increase in both patient questions and demand for hormone therapy. Women who were previously hesitant are now more open to the conversation, and many are coming in specifically asking about options they may have avoided in the past.

We are already seeing the impact in real time. Since the removal of the black box warning, there has been a noticeable increase in interest in hormone therapy…so much so that we’re currently seeing shortages of estradiol patches. That alone speaks to how strongly patient perception has shifted.

What is interesting is how differently patients are interpreting the change. Some view it as reassurance and are ready to move forward, sometimes quickly. Others are still cautious, holding onto concerns shaped by earlier messaging from the WHI. So, the conversations have increased, but more importantly, the need for clarity has increased. Patients are not just asking if hormone therapy is safe anymore; they’re asking whether it is right for them. That is a much more productive place to start.

Pharmacy Times: How can pharmacists help bridge the gap between evolving evidence and patient understanding?

Fowler: Pharmacists are uniquely positioned to bridge this gap because we sit at the intersection of medication expertise and patient access. As the evidence around hormone therapy evolves, our role is to translate that information into clear, practical guidance that patients can actually understand and use. That means moving beyond outdated, one-size-fits-all messaging and helping patients make sense of how current evidence applies to their individual situation.

We also play a key role in correcting misconceptions, whether that’s lingering fear from earlier data or the assumption that updated labeling means hormone therapy is universally safe. Equally important is reinforcing that hormone therapy is not a stand-alone solution. It should be part of a broader conversation that includes lifestyle, metabolic health, and ongoing monitoring.

Ultimately, pharmacists help bridge the gap by creating space for informed, balanced conversations, where patients feel comfortable asking questions, understand their options, and can make decisions based on clarity rather than confusion.

Pharmacy Times: How should pharmacists respond when patients request hormone therapy based on media coverage or social media trends?

Fowler: Pharmacists should approach these conversations with curiosity, not correction. Often, the patient asking about hormone therapy isn’t just following a trend—she is the woman who has been up at 2 AM, googling her symptoms because she cannot sleep anyway, trying to piece together why she suddenly feels anxious, exhausted, or unlike herself. By the time she walks into the pharmacy, she has already been searching for answers. That deserves to be acknowledged.

At the same time, it is our responsibility to bring the conversation back to clinical context. Hormone therapy is not something that should be started based on media coverage or the latest social influencer trends alone. It requires an individualized approach: considering symptoms, medical history, timing, and appropriate evaluation.

Pharmacists can help bridge that gap by validating what the patient is experiencing while also guiding her toward better questions, more reliable information, and appropriate next steps. It is not about shutting down what she has seen or heard; it is about helping her make sense of it. When handled well, these conversations shift from reactive decisions to informed ones, where patients feel supported, understood, and better equipped to understand and navigate their options.

Pharmacy Times: Do you anticipate further changes to labeling or prescribing patterns in the coming years? How should pharmacists prepare and stay up to date on these potential changes?

Fowler: Yes, I do anticipate continued changes, both in labeling and in prescribing patterns, as our understanding of hormone therapy continues to evolve. We are already seeing a shift toward more individualized care, and I expect that to deepen, particularly around timing, formulation, and route of administration. I also anticipate more formal guidance around testosterone use in women, including clearer dosing standards, as this is an area where clinical use has outpaced regulatory structure.

As this space evolves, I don’t think compounding should be left out of the conversation. In a category of medicine that is inherently nuanced and patient-specific, compounding plays an important role in allowing for individualized dosing and formulation when commercially available options don’t fully meet patient needs. Organizations like [Professional Compounding Centers of America] have contributed to advancing education and quality standards in this area, and that support becomes increasingly relevant as demand for personalized therapy grows.

For pharmacists, staying current will require a proactive and open-minded approach. That includes following updates from professional organizations like TMS and ACOG, engaging with compounding education resources, reviewing emerging literature, and being willing to reevaluate long-held assumptions as new data become available. It also means recognizing that this is an evolving area of practice, one that requires both clinical judgment and a willingness to adapt.

Preparation is not just about keeping up with changes, but it is about being equipped to deliver thoughtful, individualized care in a space that continues to move toward personalization.

Pharmacy Times: Any final/closing thoughts?

Fowler: If there is one thing I would leave pharmacists with, it is this: we have the opportunity to be the voice that says, “I hear you. I see you, and I understand that something doesn’t feel right.”

Many of these women have already been told their labs are “normal,” that this is just part of aging, or that it is something they simply have to tolerate, because the women before them did. By the time they reach us, they are often frustrated, dismissed, and still searching for answers. We are often the last clinical touchpoint before a therapy is started…or not started. That moment matters. Even when labs fall within range, patients may not feel normal. Perimenopause, in particular, can feel like a moving target, a proverbial roller coaster ride, a constant fluctuation that affects sleep, mood, cognition, and overall quality of life. Dismissing that experience because it doesn’t fit neatly into a lab value misses the bigger picture.

This is where pharmacists can have a meaningful impact. Validation is powerful. Taking a moment to acknowledge what a patient is experiencing, whether it is persistent brain fog, emotional volatility, or a sense that they no longer recognize themselves, can change how supported they feel in their care.

These symptoms are not trivial. They affect how women function in their daily lives, and they deserve to be taken seriously. When appropriate, hormone therapy can be part of that support, but just as important is ensuring the patient feels heard, understood, and guided. A small moment of empathy can shift a woman’s entire health care experience, and in this population, that may be one of the most important roles we play.