U.S. FDA· FDA·· 6 hours agoPickScore71
Hormone Replacement Therapies Can Help Women with Bothersome Menopausal Symptoms
In brief
The FDA has requested that all menopausal hormone therapy (MHT/HRT) products containing estrogen or progestogen remove risk statements about cardiovascular disease, breast cancer, and probable dementia from their boxed warnings, while updating safety information in the labels; these risks remain in the precautions section. Several companies have completed label changes approved by FDA. The endometrial cancer risk for systemic estrogen-alone products was not required to be removed.
Why it matters
FDA requested removal of these risk statements after reassessment, while keeping the risks in the label's precautions section.
Source: U.S. FDA