The Food and Drug Administration (FDA) announced this week that it is removing “black box” safety warnings from all hormone therapy treatments used to address symptoms of menopause and perimenopause in women. Black box warnings are the FDA’s strongest labels used to cite a certain drug’s risk to human health which often discourages providers and patients from its use, even when it could be beneficial.
In a press conference on Monday, FDA Commissioner Marty Makary declared the governing body will “stop the fear machine steering women away from this life-changing, even lifesaving treatment,” noting the decision is “based on a robust review of the latest scientific evidence.”
Scrutiny around the safety of estrogen-related hormone therapies emerged largely through a single study in 2002 that overstated HRT’s association with breast cancer and stroke. This led to widespread denial of hormone therapies by medical providers – and the general public – as a tool to help mitigate often debilitating symptoms experienced by most women throughout their transition to menopause. Since then, rigorous scientific evidence has instead associated hormone therapies (when used appropriately) not only with alleviating symptoms of hormone decline like hot flashes, sleep disruptions, and mood changes, but also with protecting heart, bone, and brain health.
The new label requirements will provide a more detailed explanation of potential risks of estrogen products to enable patients and providers to discuss more openly about the decision to begin treatment.
“This doesn’t change the fact that safety around HRT is of utmost importance when considering any hormone therapy protocol,” notes Dr. Jay Stevens, owner and medical director of Essential Health – Cary. “While this is positive news, there are still considerations to be made around the quality of hormone sourcing and access to regular monitoring and personalized guidance from a credentialed hormone health expert.”
Nevertheless, removing the warning label also removes an antiquated barrier to life-changing treatments for women.
“Hormone therapy is life-giving for most of the women we work with,” says Dr. Elizabeth Sierakowski, owner and medical director of Essential Health – Raleigh. “The FDA’s decision aligns with what we’ve valued and practiced for years. It has always been our goal to empower women to know their own potential risks and benefits so they can take control of their present and future health. We’re thrilled conventional medicine is officially catching on.”
Learn more about our programs that support hormone balance and schedule a time to speak to member of our team if you think hormones might be at the root of your symptoms.