from Heartwire — a professional news service of WebMD

By Sue Hughes, Medscape Alerts – January 22, 2008 (Rockville MD) – The US FDA has updated the labeling for the Ortho Evra contraceptive transdermal patch to include the results of a new epidemiology study that found that users of the patch were at higher risk of developing venous thromboembolism (VTE) than women using oral contraceptive pills.
The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson.

“For women who choose to use contraceptives, it is important that they thoroughly discuss with their healthcare providers the risks and benefits involved,” said Dr Janet Woodcock (FDA Center for Drug Evaluation and Research). “This is an example of the FDA working in tandem with the drug manufacturer to keep the public informed of new safety data and epidemiologic studies that might impact health decisions about the use of FDA-approved products,” she added.
In September 2006, the FDA revised the label for Ortho Evra to warn women about the risk of VTE based on two epidemiology studies. One study showed that some women using the patch were at a two-fold greater risk of developing VTE. The other study showed no increased risk compared with women using oral contraceptives containing 30 to 35 μg of estrogen and the progestin norgestimate.

Ortho Evra is a prescription patch containing ethinyl estradiol and norelgestromin. The FDA notes that women using the product will be exposed to about 60% more estrogen than if they were using typical birth control pills, which contain 35 μg of estrogen. Increased levels of estrogen can increase the risk of side effects, including VTE. Women should discuss with their healthcare providers the possible increased risk of VTE with Ortho Evra, which is applied once a week, and balance this risk against the increased chance of pregnancy if women do not take their birth control pill daily, it adds.
The agency says it 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 healthcare provider about Ortho Evra and other contraceptive options.

The complete contents of Heartwire, a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.

Sue Hughes is a journalist for Medscape. She joined theheart.org, part of the WebMD Professional Network, in 2000. She was previously science editor of Scrip World Pharmaceutical News. Graduating in pharmacy from Manchester University, UK, she started her career as a hospital pharmacist before moving as a journalist to a UK pharmacy trade publication. She can be reached at Shughes@medscape.net.

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