New Data on Thromboembolic Events with Ortho Evra Contracept

The prescribing information for the Ortho Evra Contraceptive Transdermal Patch is being updated with results of a new study on the risk of venous thromboembolism. This study found that women aged 15-44 who used the birth control patch were at higher risk of developing venous thromboembolism than women using birth control pills.

These findings support an earlier study that also concluded that women in this group were at higher risk of venous thromboembolism. Another earlier study found that women using the patch did not have a greater risk.

However, the results from the two positive studies support concerns that the patch could increase the risk of blood clots in some women. The label continues to recommend that women with concerns or risk factors for thromboembolic events talk with their healthcare provider about using Ortho Evra versus other contraceptives.

FDA Patient Safety News: April 2008

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=74#5

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Education

Tags:

• Ortho
• Evra
• contraceptive
• patch
• FDA
• birth
• control
• blood
• clots