Feburary 16, 2006

FDA and Wyeth revised the prescribing information of Premarin, Prempro, and Premphase to include a boxed warning which includes risk information from the Women's Health Initiative (WHI) study. The increased risks of Premarin plus medroxyprogesterone compared to placebo are as follows for a 5-year period. For every 10,000 women treated with Premarin plus medroxyprogesterone, 7 more women would experience a coronary event, 8 more women would experience invasive breast cancer, 8 more women would experience a stroke, and 8 more women would experience a pulmonary embolism compared to 10,000 women treated with placebo.

The arm of the trial comparing placebo to Premarin alone in women who have previously had a hysterectomy was allowed to continue and the results were recently published. For every 10,000 women treated with Premarin monotherapy, 12 more women would experience a stroke compared to 10,000 women treated with placebo. There were several benefits of Premarin monotherapy. For every 10,000 women treated with Premarin monotherapy, 7 fewer women would experience breast cancer, 56 fewer women would experience an osteoporotic fracture (including 6 fewer hip fractures and 6 fewer vertebral fractures) compared to 10,000 women treated with placebo. The risk of coronary heart disease was 9% lower with Premarin monotherapy (or 5 fewer events per 10,000 women) than placebo, although this was not statistically significant.

• Letter to healthcare professionals
   
• MedWatch 2003 Safety Information Summary
   
• Letter to healthcare professionals 2006