The FDA is asking companies to remove black box warnings on hormone therapy for menopause, and many experts agree.
A black box warning, which appears in a black-bordered box on a medication, is a warning to healthcare providers that the medication may cause serious adverse effects. The original black box warning for hormone therapy was based on a 2002 study from the Women’s Health Initiative (WHI) that found increased risk of stroke, breast cancer, and cardiovascular disease among women ages 50-79 taking hormone therapy compared to those who didn’t. After the black box warning, hormone therapies remained on the market, but prescriptions plummeted.
Since 2002, there has been much debate and much more research following the findings of the Women’s Health Initiative study. Since then, studies have not always replicated these risks and have even suggested other health benefits of taking hormone therapy. There are no data to suggest large decreases in cardiovascular or Alzheimer’s risk, as the current FDA commissioner has said.
The Menopause Society’s position statement encourages shared decision making with your clinician about starting hormone therapy before age 60 or within 10 years of menopause to help with peri/menopausal symptoms (See list of possible symptoms here). Guidance about using the lowest dose for the shortest amount of time will be removed, opening up the option for many people to stay on these therapies for longer. Many experts agree with this move, although they also caution that individual risks and benefits should always be discussed with a clinician. There was also concern in the medical community that the FDA didn’t follow a typical process for this kind of decision. The panel was a short, informal conversation between officials and scientists rather than the usual practice of a formal review process by a convened advisory panel.
Does this “reversal” mean we didn’t know what we were talking about in the first place? Or perhaps that we don’t know what we’re talking about now? Not really. The WHI study was rigorous and methodologically sound, but the conclusions were exaggerated in initial reporting and led to a situation in which the risks of hormone therapy were somewhat overblown for a long time. The notion that hormone therapy is universally more risky than beneficial is not really true, and we see action being taken to ensure that clinical guidelines and drug labels follow suit. In the end, the data are still nuanced, however, and we should be careful not to jump to the conclusion that hormone therapy will be a cure-all for all people under all circumstances. The risks and benefits calculation can still be complex and best left up to individuals to discuss with their clinicians. It’s likely a good thing to remove a warning that was reducing access to this important form of treatment, but we must still be thoughtful about any universal statement that brands any therapies as uniformly “good” or “bad.” In short, if you want to look into hormone therapy further, don’t be afraid. There are many benefits to these therapies, and they are a highly viable option for many people.
Further reading:
The Menopause Society’s position statement
Office of Women’s Health – Menopause symptoms and relief
Jen Gunther “ the Vajenda” – Reaction to the FDA announcement on MHT
Those Nerdy Girls – I’m in perimenopause. What is happening to my brain? and Hot flashes and mood swings in perimenopause! Make ‘em go away!
