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ORTHO EVRA(R) Prescribing Information Updated
Date:1/18/2008

RARITAN, N.J., Jan. 18 /PRNewswire-USNewswire/ -- Ortho Women's Health & Urology(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has updated the prescribing information for ORTHO EVRA(R) (norelgestromin/ethinyl estradiol transdermal system) to include further epidemiologic data.

The revised labeling includes two new additional estimates of relative risk (odds ratios) for venous thromboembolic events (VTE) of 1.1 (indicating no increase in risk) and 2.0 (indicating an approximate doubling of risk) in women using ORTHO EVRA compared to women using birth control pills. The previous labeling reported two estimates of relative risk for VTE of 0.9 (indicating no increase in risk) and 2.4 (indicating an approximate doubling of risk). This information is presented in a table in the WARNINGS section and is available at http://www.fda.gov and http://www.orthoevra.com. The results from all of these epidemiologic studies can be found on http://www.clinicaltrials.gov or by calling Ortho-McNeil Janssen Scientific Affairs, LLC Customer Communications Center at 1-800-526-7736.

The detailed patient information for ORTHO EVRA also has been revised to include this information in the OTHER CONSIDERATIONS BEFORE USING ORTHO EVRA section.

ORTHO EVRA is a hormonal birth control option and is safe and effective when used according to the product label. The Company consulted with the U.S. Food and Drug Administration on this label change. ORTHO EVRA, like all hormonal birth control, has risks and benefits. It is important that women speak to their health care professional to determine the option that is right for them.

ORTHO EVRA is indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception.

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SOURCE Ortho Women?s Health & Urology
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