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FDA Warns of Serious Blood Clot Risk in Women on Ortho Evra (Norelgestromin/Ethinyl Estradiol)
BETHESDA, MD -- September 21, 2006 -- Ortho and FDA notified healthcare professionals and patients about revision to the prescribing information to inform them of the results of two separate epidemiology studies that evaluated the risk of developing a serious blood clot in women using Ortho Evra (norelgestromin/ethinyl estradiol) compared to women using a different oral contraceptive.
The first study found that the risk of non-fatal venous thromboembolism (VTE) associated with the use of Ortho Evra contraceptive patch is similar to the risk associated with the use of oral contraceptive pills containing 35 micrograms of ethinyl estradiol and norgestimate. The second study found an approximate 2-fold increase in the risk of medically verified VTE events in users of Ortho Evra compared to users of norgestimate-containing oral contraceptives containing 35 micrograms of estrogen.
Although the results of the two studies differ, the results of the second study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women.
Prescribing information for Ortho Evra continues to recommend that women with concerns or risk factors for thromboemboli disease talk with their healthcare professionals about using Ortho Evra versus other contraceptive options.
SOURCE: U.S. Food and Drug Administration
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