Estrogen-related medications for menopause will no longer carry broad black-box warnings, Marty Makary, commissioner of the US Food and Drug Administration (FDA), announced last week, bypassing the regulatory agency’s typical process and, according to experts, overstating the science behind the medications – with troubling implications for future drug decisions.
The decision to remove an ominous warning from 2003 about the risks of cardiovascular disease, breast cancer and dementia makes sense for local vaginal estrogen products, but systemic estrogen is more complicated, menopause experts said – and more than these nuances, they worried about the scientific process, or lack thereof, in making the decision.
