drugs information

Prempro/Premphase Black Box Warning

Market Name: Prempro/Premphase

Generic Name: Conjugated estrogens

Prempro/Premphase is an estrogen therapy intended to treat the symptoms of menopause, including moderate to severe hot flashes, moderate to severe dryness, itching, and burning, and weakening bones that can lead to osteoporosis.

A black box warning was added by the FDA in July of 2006 warning of increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary embolism and deep vein thrombosis in post-menopausal women with the use of Prempro/Premphase.

Black Box Warning Date: July 2006

FDA Link: Prempro/Premphase

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