Exciting News! FDA removes Black Box Warning
Back in 2003, after the Women’s Health Initiative (WHI) study was published, the FDA used data collected from that study to place a black box warning on all estrogen products sold in the US. The reasoning for this was that the WHI claimed that hormone therapy increased the risk of multiple diagnoses such as heart disease, blood clots, and breast cancer. But over the last 22 years, women’s health experts continued to extrapolate the data and showed that the original conclusions were misinterpreted. The results were catastrophic. A generation and a half of women went through the menopause transition being told to avoid hormones at all costs and providers were taught to not consider these medications in midlife care. This resulted in these women having to suffer the effects of hot flashes, night sweats, mood changes, bone loss, and as it turns out, an INCREASED risk of cardiovascular disease due to the lack of estrogen.
Fortunately for those of us in the current midlife landscape, a small but growing group of experts were vocal and brought receipts! Study after study, showing both the fallacy of the WHI’s conclusions and the data that supported the usage of hormones for health and longevity, were presented to the FDA. On Monday, they officially removed the black box warning.
Why does this matter? The black box warning inhibited patient-centered care. Providers generally want to mitigate adverse reactions to medication and they certainly do not want to increase anyone’s chances of a cancer. It shaped how future medical providers were taught. It limited access to medication plans on insurance. It took away an option from women who were suffering. And that is why this is a big deal!
This does not mean that all women are eligible for estrogen therapy but it allows for expansion and research to determine what is safe and for whom it is safe. It again re-emphasizes the reason that it is so important for women to seek out care in someone who has furthered their studies and trained on the usage of hormone therapies. Many providers have used the black box warning as their scapegoat to not prescribe these life-saving medications to anyone.
If you have been told, “No, our office doesn’t prescribe that” or “You can only take those if you have no family history of cancer” or even, “You are not old enough to be experiencing symptoms,” you deserve better. At Sapphire Wellness, we will review YOUR personal medical history, YOUR FAMILY’S medical history and discuss what is available and what is not an option. We will tailor a plan that works for you and we will walk with you if we need to change or alter anything to achieve better results. This significant change in status of these meds shows that we have to evolve in medicine and also that you don’t have to just suffer through this time of your life!
