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FDA: Birth Control Patch Needs More Study

February 17, 2006

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The Food and Drug Administration has raised concerns about blood clot risks associated with Johnson & Johnson's birth control patch, but said it plans no action until it can study the risk more closely.

The FDA issued a statement after early results of a study indicated users of the birth control patch were two times more likely than others to develop blood clots in the legs and lungs.

Dr. Daniel Shames, director of the FDA's division of reproductive and urologic drug products, says scientists need to understand what, if any, connection exists.

Johnson & Johnson introduced ORTHO EVRA, the first FDA-approved birth control patch, in April 2002. It was promoted as being as effective as birth control pills, but required only weekly dosing.

ORTHO EVRA is a thin beige patch worn for one week at a time and is replaced on the same day of the week for three consecutive weeks. The fourth week is "patch-free," according to the company.

Like the Pill, ORTHO EVRA contains two hormones – an estrogen, ethinyl estradiol, and a progestin, norelgestromin. When a woman applies the patch to her body, these hormones are released from the patch at constant and continuous levels each day. As these hormones are absorbed through the skin and pass into the bloodstream, they work just like the pill to prevent pregnancy, according to the company.

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