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Warning Added to Birth Control Patch

Ortho Evra Patch Exposes Women to More Estrogen Than Birth Control Pills; May Raise Risk of Blood Clots, Says FDA

Maker's Statement

Ortho Evra's maker, Ortho-McNeil Pharmaceutical, issued a news release about the label change.

The news release echoes many of the points covered by the FDA. It also notes that Ortho Evra has been used by more than 5 million women and "remains a safe and effective product, when used according to the product's label. However, hormonal contraception is not suitable for all women. It is important that women speak with their healthcare professionals about what option is right for them."

The company also states that "most side effects of the patch are not serious and those that are occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke, and heart attacks, and are increased if you smoke cigarettes.

"Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the patch are strongly advised not to smoke," the news release states.

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