Daniel Shames, controller of FDA's Division of Reproductive and Urologic Drug Products, resting on Friday bid the grades from two Ortho-McNeil-funded study, which correlation the Ortho Evra birth costs patch to an increased hazard of blood clot, "preliminary" and said regulatory act be not looked-for, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 2/18). One of the studies -- which be conduct via i3 Drug Safety, an Ingenix subsidiary, and released new building week -- compare the joint risk of heart bag-snatch, hold and blood clots interior the legs or lungs in women using Ortho Evra and women taking oral contraceptive pills contain norgestimate and estrogen. The den do not find an increased combined risk in support of heart attack or stroke in women taking Ortho Evra, but patch user enjoy about double the risk of blood clots by money of the women taking the pills. A pull apart manufacturer-funded study compare Ortho Evra users to dose users examine a database of 200,000 women and indicate that the risk of blood clots was harmonizing involving the two delivery. That study, which was conducted by the Boston Collaborative Drug Surveillance Program and published in the Jan. 30 online edition of the memoir Contraception, also did not find an increased risk for heart attack or stroke among women using Ortho Evra, but evaluation of the notes is ongoing (Kaiser Daily Women's Health Policy, 2/17). Shames said, "We're not certain what this means clinically, but it's news that race stipulation to know about" (Los Angeles Times, 2/18). Shames said women should consult their doctors when decide on a way of birth control, adding together, "For complex than a few people the patch may be advanced because some people don't reliably erect the pill or don't want to take the pill or forget the pill." He said, "On the other foot, these results be first performance, hence we can't pioneer rock-hard remarks about it" (Schmid, AP/Philadelphia Inquirer, 2/18). Shames said FDA at this time is review the study results, and he trust the enterprise to submit more data by May (Corbett Dooren, Wall Street Journal, 2/21).CBS' "Evening News" on Friday report on the study. The segment embrace comments from Shames; a gynecologist who prescribe the patch; and a user of the patch (Bowers, "Evening News," CBS, 2/17). The ample segment is going spare online in RealPlayer.
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