Revised Warning for Ortho Evra Patch

-FDA News

01/28/2008 -  The warnings section of physician labeling for Johnson & Johnson’s (J&J) birth control patch Ortho Evra was updated Jan. 18 to reflect data from a new epidemiology study that found the product increases the risk of venous thromboembolism (VTE) when compared with traditional birth control pills. VTE can lead to pulmonary embolism, the FDA said.

The agency originally updated the Ortho Evra (ethinyl estradiol/norelgestromin) label with information from two epidemiology studies, one of which found that use of the transdermal patch doubled a patient’s risk of VTE when compared with birth control pills. The other study did not find an increased risk of VTE.

However, results from the new study found a VTE safety risk. In all of the studies, the patch was compared with birth control pills that contained ethinyl estradiol and either norgestimate or levonorgestrel.

The Ortho Evra patch is marketed by J&J subsidiary Ortho-McNeil.

If you or someone you love has used the Ortho Evra Birth Control Patch and has experienced side effects such as: heart attack, stroke, blood clots, or deep vein thrombosis (DVT) you need to know your legal rights. Call our Ortho Evra side effects lawyers for a free legal consultation or to ask questions about a possible Ortho Evra lawsuit or Ortho Evra recall.