Orth Evra Labeling Information Changed

The Food and Drug Administration (FDA) released the following information:

MedWatch - The FDA Safety Information and Adverse Event Reporting
Program

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.