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Written by Theresa Maher   
Sunday, 20 January 2008
SATURDAY, JAN 19, (News Locale) - The U.S. Food and Drug Administration (FDA) is warning women that using birth control patch as a contraceptive method increases their risk of developing venous thromboembolism (VTE). The condition is better known as blood clots and can even prove fatal.

The FDA issued this warning while approving labelling changes to Ortho Evra Contraceptive Transdermal (Skin) Patch. The new label will reflect the findings of a new study where women using the birth control patch were at a higher risk of developing lethal blood clots as compared to women using the Pill.

Ortho Evra is a popular method used as a means of contraception among American women. It releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) into the skin. The patch was approved by the FDA in 2001.

The FDA explained that hormones released by the patch are processed differently by the body as opposed to hormones available from birth control pills. Basically women using Ortho Evra will be exposed to 60 percent more estrogen than what is released by the pills.

It is a known fact high levels of estrogen increase the risk of lethal blood clots or VTE.

"The 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 agency revealed yesterday.

This is not the first time the clotting effect of birth control patches in under the FDA scanner. Back in September 2006, the agency had changed the labeling information on the product following results from two epidemiological studies that suggested increased risk of blood clots in women using the patch.

In the current study Boston Collaborative Drug Surveillance Program (BCDSP) found women using birth control patch were at higher risk of developing serious blood clots than women using birth control pills. The study was conducted for leading drug company Johnson and Johnson, which owns Ortho McNeil Pharmaceuticals. The latter is the manufacturer of Ortho Evra.

Blood clots are also called venous thromboembolisms (VTEs) and can travel through the body and end up in the lungs causing potentially fatal pulmonary embolisms. Birth control pills are known to increase the risk of developing blood clots since a long time. However it now appears they are safer to use than the patch.
 

 
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