FDA Official Calls Results Of Ortho Evra Birth Control Patch Studies 'Preliminary'; No Regulatory Action Expected

Daniel Shames, director of FDA's Division of Reproductive and Urologic Drug Products, on Friday called the results from two Ortho-McNeil-funded studies, which link the Ortho Evra birth control patch to an increased risk of blood clots, "preliminary" and said regulatory action is not expected, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 2/18). One of the studies -- which was conducted by i3 Drug Safety, an Ingenix subsidiary, and released last week -- compared the combined risk of heart attack, stroke and blood clots in the legs or lungs in women using Ortho Evra and women taking oral contraceptive pills containing norgestimate and estrogen. The study did not find an increased combined risk for heart attack or stroke in women taking Ortho Evra, but patch users had about double the risk of blood clots as the women taking the pills. A separate manufacturer-funded study comparing Ortho Evra users to pill users examined a database of 200,000 women and showed that the risk of blood clots was similar between the two groups. That study, which was conducted by the Boston Collaborative Drug Surveillance Program and published in the Jan. 30 online edition of the journal Contraception, also did not find an increased risk for heart attack or stroke among women using Ortho Evra, but evaluation of the data is ongoing (Kaiser Daily Women's Health Policy, 2/17). Shames said, "We're not sure what this means clinically, but it's information that people need to know about" (Los Angeles Times, 2/18). Shames said women should consult their doctors when deciding on a method of birth control, adding, "For some people the patch may be better because some people don't reliably take the pill or don't want to take the pill or forget the pill." He said, "On the other hand, these results are preliminary, so we can't make hard comments about it" (Schmid, AP/Philadelphia Inquirer, 2/18). Shames said FDA currently is reviewing the study results, and he expects the company to submit more data by May (Corbett Dooren, Wall Street Journal, 2/21).

CBS' "Evening News" on Friday reported on the study. The segment includes comments from Shames; a gynecologist who prescribes the patch; and a user of the patch (Bowers, "Evening News," CBS, 2/17). The complete segment is available online in RealPlayer.


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