FDAnews
www.fdanews.com/articles/142732-contraceptive-patch-should-stay-but-with-stronger-labeling-rems

Contraceptive Patch Should Stay, But With Stronger Labeling, REMS

December 27, 2011
A joint FDA advisory panel is recommending Janssen Pharmaceuticals’ Ortho Evra transdermal contraceptive patch remain on the market as its benefits outweigh the risk of blood clots for most women. However, new labeling is needed to clearly reflect the risk-benefit profile, it says.
Devices & Diagnostics Letter