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GENERAL INFORMATION |
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September 20, 2006 FDA- MedWatch - Ortho Evra (norelgestromin | ethinyl estradiol) |
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| 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 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. |
| Read the complete MedWatch 2006 Safety summary, including links to the
Sponsor's updated prescribing information and the FDA's Q&As regarding
this issue. |
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