Estrogens - Progestins Warning Update - FDA and Wyeth Revise Warning For Premari

Prescribing information for Premarin, Prempro, and Premphase will now include a boxed warning for physician's who prescribe estrogens and/or progestins for menopausal women.

The warning says that estrogens with or without progestins should not be used for the prevention of cardiovascular disease. Included in the warning box is risk information derived from the Women's Health Initiative (WHI) study which found increased risks of:

• myocardial infarction
  
• stroke
  
• invasive breast cancer
  
• pulmonary emboli
  
• deep vein thrombosis.

The study included postmenopausal women who were treated for five years with conjugated equine estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo.

Because of these risks, health care providers should prescribe estrogens with or without progestins at the lowest effective dose and for the least amount of time required to acheive individual risk and treatment goals for each woman.

Dear Health Professional Letter

The following links are in PDF format from the FDA, and require Adobe Acrobat Reader (free download).

• Revised Label For Premarin
  
  
• FDA Aproval Letter
  
  
• Revised Label For PREMPRO
  
  
• FDA Aproval Letter

Source: FDA/CDER