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Ortho Evra Study Shows Blood Clot Risk

–February 17, 2006

According to the makers of the Ortho Evra birth control patch, women who use this form of contraception face twice the risk of developing blood clots, compared to women using oral contraceptives. Ortho McNeil, a subsidiary of Johnson & Johnson, stated that these preliminary findings were produced through a company-sponsored study and have been shared with the FDA.

Ortho Evra, the first and only FDA-approved hormonal contraceptive patch, has been widely scrutinized in recent months, due to numerous reports of young healthy women suffering blood clots (including deep vein thrombosis and pulmonary embolism), heart attack, stroke, and other life threatening side effects while using the patch. In November 2005, Ortho McNeil announced that women using the patch were exposed to 60 percent more estrogen that women taking the pill.

High levels of estrogen have long been associated with serious thrombotic events.

The makers of Ortho Evra have announced that one company study showed no increased risk of blood clots, while the other found a two-fold risk of blood clots in the legs and lungs in women using the patch. Researchers are still evaluating the risks of heart attack and stroke in these studies.

The FDA has stated that further evaluation is necessary in order to understand the blood clot risks associated with the Ortho Evra birth control patch.

Over 20 women have died or suffered serious thrombotic injury while using the patch. Many of these women were young and healthy. Despite these reports, Ortho McNeil maintains that the patch does not pose an increased risk of serious adverse events, in comparison to oral contraceptives. At least four million women have used the potentially defective Ortho Evra birth control patch.

Several Ortho Evra lawsuits have been filed on behalf of women who have suffered serious side effects while using the patch.


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