Last Friday, an FDA advisory panel voted 19 to 5 that the Ortho Evra birth control patch be allowed to remain on the market. Members of the panel ultimately found that the benefits of using the patch outweighed the potential increased risk for blood clots. Although, the panel did vote in favor recommending that information regarding the increased risk for blood clots be clearly stated on the product’s label.
To be more specific, members of the Advisory Committee for Reproductive Health Drugs, along with members of a Drug Safety Committee, voted to recommend to the FDA that the agency allow the Ortho Evra norelgetromin/ethinyl estradiol transdermal patch to remain a contraceptive option for women who cannot or do not take birth control pills at the same time each day.
Ironically, this same panel convened just the previous day and voted (15 to 11) that the benefits of drospirenone-containing birth control pills like Yaz also outweigh its risk for blood clots (venous thromboembolism, VTE).
While Ortho Evra does not contain drospirenone, it does contain higher levels of estrogen compared to older birth control options. An FDA postmarketing report released in October revealed that the patch, the vaginal ring and birth control pills containing drospirenone were all linked to a higher risk for VTE compared to older-generation hormonal contraceptives that have lower doses of estrogen.
It is important to note that the U.S. Food and Drug Administration is not required to follow the recommendations of its advisory panels, although it often does.
