[Fwd: MedWatch - Ortho Evra Contraceptive Transdermal Patch: New study shows higher risk of developing serious blood clots]

FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an earlier study that also said women in this group were at higher risk for VTE.

FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.

Read the complete 2008 MedWatch Safety Summary, including a link to the FDA News Release, at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#orthoevrapatch

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FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an earlier study that also said women in this group were at higher risk for VTE.

FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.

Read the complete 2008 MedWatch Safety Summary, including a link to the FDA News Release, at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#orthoevrapatch

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) . 5600 Fishers Lane . Rockville MD 20857 . 800-439-1420