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.