FDA Panel: Transdermal Birth Control Patch OK to Market

Emma Hitt, PhD

December 09, 2011

December 9, 2011 — Voting in favor of the norelgestromin/ethinyl estradiol transdermal contraceptive patch (Ortho Evra, Jannsen), a US Food and Drug Administration (FDA) advisory panel today determined whether the benefits currently outweigh the risks for venous thromboembolism (VTE), with 19 voting in favor and 5 voting against.

However, in a second vote, the panel members also said that those risks should be more clearly stated on the label.

The votes were cast today in the second of a 2-day Joint Meeting of the FDA's Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee.

The panel convened to discuss the benefits and risks of the transdermal birth control patch given the risk for VTE associated with use of these products.

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?" Of the panelists, 19 voted "yes" and 5 voted "no."

Panelist Geri D. Hewitt, MD, from the Department of Obstetrics and Gynecology at Ohio State University in Columbus, who voted "yes," 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 "yes," pointed out 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 5 who voted "no," Richard Bockman, MD, PhD, head 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." However, he added that in the subpopulation of patients who decline any other form of contraception, the risk/benefit profile of this 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?" 3 voted "yes" and 20 voted "no," suggesting that they feel the risk information on the label should be enhanced.

The outcomes for the two votes cast today are similar to the ones cast yesterday for drospirenone-containing oral contraceptives, in which the joint panel also found that the benefits were worth the risks but that the information on the label should better reflect these risks.

The FDA does not always follow the advice of the advisory panels, but it usually does.


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