Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate tablets) August 2002
Audience: Reproductive healthcare professionals
FDA and Wyeth notified healthcare professionals about safety related labeling changes to the INDICATIONS and USAGE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE and ADMINISTRATION sections of the labels. The new safety information reflects new data, primarily from the Women's Health Initiative (WHI).
[August 28, 2002 - Letter - Wyeth]
[August 13, 2002 - FDA Statement on the Results of the Women's Health Initiative - FDA]