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Prempro FDA Alerts

The FDA Alerts below may be specifically about Prempro or relate to a group or class of drugs which include Prempro.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Prempro

Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate tablets)

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


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