Market Name: Activella

Generic Name: Estradiol/Norethindrone acetate

Activella is an estrogen-containing therapy for physical symptoms related to menopause.

The Women's Health Initiative (WHI) Study reported an increased risk of heart attack, stroke, blood clots, and invasive breast cancer in post-menopausal women between the ages of 50 and 79 taking estrogens with or without progesterone. A black box warning was added to Activella’s prescribing information by the FDA in December 2006 explaining that due to these findings, the lowest possible dose consistent with the patient’s goals should be prescribed.

Black Box Warning Date: December 2006

FDA Link: Activella