Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee

Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
Meeting on December 9, 2011, from 8 a.m. to 5 p.m. (Day 2 of 2)

Agenda: On December 9, 2011, the committees will discuss the benefits and risks of ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system), marketed by Janssen Pharmaceuticals, Inc., for the prevention of pregnancy. Specifically, the committees will discuss the possibly increased risk of thrombotic (blood clots) and thromboembolic events (blood clots that can break loose and move within the circulatory system) in users of ORTHO EVRA compared to women who use commonly prescribed birth control pills, as suggested by postmarketing studies.