FDA panel okays marketing of transdermal contraceptive patch
WASHINGTON, DC –– On December 9, a Food and Drug Administration (FDA) advisory panel voted in favor a transdermal contraceptive patch manufactured by Jannsen: Ortho Evra (norelgestromin/ethinyl estradiol). The panel voted on whether the benefits off the transdermal contraceptive patch currently outweigh the risks for venous thromboembolism (VTE); 19 voted in favor of Ortho Evra and 5 voted against. However, in a second round of voting, the panel members also said that those risks should be more clearly stated on the label. The voting took place on the second day of a two-day Joint Meeting of the FDA's Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. The purpose of the meeting was to discuss whether the contraceptive benefits outweighed the risks of VTE for the transdermal contraceptive patch.
The first vote was in response to the question: "Do you believe that, in the general population of women who desire contraception, the benefits of the Ortho Evra transdermal contraceptive patch for prevention of pregnancy outweigh the risks?" Panelist Geri D. Hewitt, MD, from the Department of Obstetrics and Gynecology at Ohio State University in Columbus, who voted in favor of the product, said, "I felt as though the risks the best we could understand them are comparable to other birth control pills that are currently on the market…and that the absolute risks became quite small. I also felt like it is a unique product — nothing else like it is available."
Melissa Gilliam, MD, MPH, from the Department of Obstetrics and Gynecology at the University of Chicago, Illinois, who also voted in favor of the transdermal patch explained that she has many teenage patients, and for them, "this is the only method of birth control that they'll use," and it "beats them getting pregnant."
Among the five who voted against the product, Richard Bockman, MD, PhD, chairman of the Endocrine Service with the Hospital for Special Surgery, New York, said that he voted no "because one has to choose the least risk particularly when there are a number of choices… I think we have a lot more choices, and many of them are lower risk." He added, however, that in the subpopulation of patients who decline any other form of contraception, the benefit/risk ratio of the product would be favorable.
In a second vote, regarding the statement "Do you believe the current Ortho Evra label adequately reflects the risk/benefit profile for the product?" three voted in favor and 20 voted against; thus, suggesting that the panelists felt that labeling in regard to risk needed enhancement. The voting outcomes in regard to the transdermal contraceptive patch were similar to those of December 8 issue regarding drospirenone-containing oral contraceptives; in that voting, the panelists also found that the benefits were worth the risks; however, they also requested that information regarding the risk should be augmented on the product label.