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Label Changes for:

Prometrium (progesterone, USP) 100 and 200 mg Capsules

June 2009

Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009

BOXED WARNING

CARDIOVASCULAR DISORDERS, BREAST CANCER, and PROBABLE DEMENTIA
  • The estrogen plus progestin substudy of the Women's Health Initiative (WHI)  reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg), relative to placebo.
  • The Women's Health Initiative Memory Study (WHIMS), an  ancillary study of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE 0.625 mg  combined with medroxyprogesterone acetate (MPA 2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
CLINICAL STUDIES, WARNINGS,  Cardiovascular Disorders, Probable Dementia, and PRECAUTIONS, Geriatric Use, Patient Package Insert 

reflect changes: 

  • to conform with class labeling for progestin drug products when progestins are used in conjunction with estrogens 
  • with published analyses and information from the Women’s Health Initiative (WHI) Postmenopausal Hormone Therapy Trials
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