View source for Directory:FDA/Update to Label on Birth Control Patch

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On January 18, 2008, FDA approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study. The study found that users of the birth control patch were at higher risk of developing serious blood clots than women using birth control pills.

Serious blood clots, also known as venous thromboembolism (VTE), can lead to pulmonary embolism (a blockage in an artery in the lung).

The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These recent findings support an earlier study that also said women in this group were at higher risk for VTE.

Ortho Evra, which is applied once a week, is a prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream.

Because the hormones are processed by the body differently than hormones from birth control pills, women using the product will be exposed to about 60 percent more estrogen than if they were using typical birth control pills containing 35 micrograms of estrogen.

Increased levels of estrogen may increase the risk of side effects, including VTE. Women should discuss with their health care provider the possible increased risk of VTE with Ortho Evra, and balance this risk against the increased chance of pregnancy if women do not take their birth control pill daily.

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.

The Ortho Evra Contraceptive Transdermal Patch is manufactured by Ortho McNeil Pharmaceuticals, a division of Johnson and Johnson.

Consumers with questions regarding this drug or any medications may contact FDA's Division of Drug Information. Phone: 888-INFO-FDA (888-463-6332) E-mail: [mailto:druginfo@fda.hhs.gov druginfo@fda.hhs.gov].

'''For More Information'''
[http://www.fda.gov/cder/drug/infopage/orthoevra/default.htm Ortho Evra Information Page]

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