Affinia Healthcare Statement on FDA Removal of Warnings from Menopausal Hormone Products

Menopause is a universal yet unique experience in which many women may suffer from uncomfortable symptoms such as hot flashes, night sweats, and vaginal and urinary symptoms.  Hormone Replacement Therapy (HRT) products are a safe option for many women – especially in the first 10 years of menopause or before 60 years of age in treating certain symptoms of menopause. 

Through advocacy and research, the decision to remove the FDA ‘black-box warning’ from estrogen products is an important step forward in reducing unnecessary barriers of use and improving access.  As always, a conversation with your doctor about your individualized symptoms, medical history, and treatment goals is recommended.  With this removal of the ‘black-box warning’, we believe menopause treatment will be placed back into the hands of patients and their health care providers to engage in shared decision making without additional fear. 

Dr. Jessica Norton, Assistant Medical Director of Reproductive Health

Dr. Melissa Tepe, VP, Chief Medical Officer