Women who use the Ortho Evra birth control patch are at a higher risk of developing venous thromboembolism than women who use birth control pills, according to an updated label approved by the US Food and Drug Administration (FDA) in January.
Previous studies comparing this patch with oral contraceptives had contradictory results (Cole JA et al. Obstet Gynecol. 2007;709[2 pt 1]:339-346; Jick S et al. Contraception. 2007;76:4-7). The new labeling reflects the results of the most recent epidemiological study comparing the incidence of venous thromboembolism in women aged 15 to 44 who were using the patch or oral contraceptives containing 30 μg of ethinyl estradiol and progestin levonorgestrel. The study, conducted by the Boston Collaborative Drug Surveillance Program, found that risk of this adverse event in women using the patch was twice as high as in women taking oral contraceptives.
Kuehn BM. Birth Control Patch. JAMA. 2008;299(8):890. doi:10.1001/jama.299.8.890-d