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Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate tablets)

September 26, 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]

[August 2002 Premarin Full Revised Label - Wyeth] 275 kb pdf file
[August 2002 Premarin Patient Package Insert - Wyeth] 218 kb pdf file
[August 2002 Prempro/Premphase Full Revised Label - Wyeth] 465 kb pdf file
[August 2002 Prempro/Premphase Patient Package Insert - Wyeth] 219 kb pdf file

[Hormone Replacement Therapy -- Latest News - National Women's Health Information Center, HHS]

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