Thursday, September 21, 2006

TOPIC: FDA Updates Warning on Contraceptive Patch - Risk of blood clots in legs, lungs prompts label change for Ortho Evra patch
Article by Steven Reinberg
HealthDay Reporter
The U.S. Food and Drug Administration said Wednesday that it has updated the label on the Ortho Evra birth-control patch, warning that some women who use the product face a higher risk of blood clots.
The label revision came after the final results of a study, commissioned by the drug's maker, Johnson and Johnson, found that users face twice the risk of clots in the legs and lungs than women taking traditional birth-control pills. But a second study, also commissioned by Johnson and Johnson, found no difference in risk between the patch and the pill. "Even though the results of the two studies are conflicting, the results of the second epidemiology study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women," the FDA said in a statement on its Web site.
"Blood clots occurring in the legs or lungs are serious and rare events that are a potential risk for all hormonal contraceptive therapies," Dr. Daniel Shames, the acting deputy director of FDA's Office of Drug Evaluation in the Center for Drug Evaluation and Research, told a press conference.
Read the entire article here - especially if you're using the patch now. There are a lot of considerations when thinking about contraception. Here's a link to a book that may help each married couple make the best decision for their family: The Contraception Guidebook: Options, Risks, and Answers

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