FDA Votes to Strengthen Warnings on Ortho-Evra Patch

Washington, DCA post-marketing report released in October by the Food and Drug Administration (FDA) on the safety of new generation contraceptives reportedly states that the Ortho Evra Patch from Johnson & Johnson's Janssen division, and the norelgestromin/estradiol vaginal ring, are associated with an increased risk for venous thromboembolic events (VTE), compared with contraceptives containing lower doses of estrogen. The Ortho Evra Patch and the ring both contain higher levels of estrogen compared with older or second generation birth control pills.

A recent meeting of a special FDA panel set up to review the safety of new generation contraceptives addressed labeling of the patch, and they voted 20-3 in favor of making the labeling more clear - that it should state the risks associated with using the patch. This will make the fourth time Janssen has changed its labeling on the patch since 2005. Earlier this year the FDA added a boxed warning to the contraceptive saying that one study found the risk for VTE to be significantly greater with Ortho Evra than with lower-estrogen birth control pills.

Lawsuits have been filed by women who allege they suffered serious Ortho Evra side effects, which reportedly include blood clots in the legs and lungs as well as heart attacks and strokes. Women who use the Ortho Evra patch allege they were harmed by use of the birth control patch, while some families claim their loved ones died after using Ortho Evra birth control.

The FDA panel also addressed safety issues related to birth control that contains drospirenone, such as Yaz/Yasmin, Beyaz and Safyral, voting overwhelmingly to strengthen the warnings on drospirenone-containing birth control, to warn patients about the risk of blood clots associated with the contraceptives. This followed an FDA released a safety announcement (September 2011) indicating a 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives. Bayer, the makers of YAZ/Yasmin, are also facing a raft of lawsuits.