The U.S. Food and Drug Administration (FDA) has updated the safety precautions on the warning label for the Ortho Evra birth control patch to remind women that their risk of blood clots in the legs and lungs may be higher if they use Ortho Evra instead of birth control pills. The warning reflects the results of a study disclosed by Johnson & Johnson in February 2006 that found women using the Ortho Evra patch risked blood clots at a rate twice as high as women on birth control pills. Johnson & Johnson owns Ortho McNeil, the company that manufactures the Ortho Evra patch.

A second study cited by Johnson & Johnson found no difference in risk between the two different forms of birth control. However, using a birth control patch exposes a patient to as much as 60 percent more estrogen than using a traditional birth control pill. Studies on the safety and efficacy of the Ortho Evra patch versus birth control pills are expected to continue for another 18 to 24 months.

More than four million women are estimated to have used the Ortho Evra patch since it was approved for sale in the U.S. in 2002. About 500 people have filed product liability lawsuits against Ortho McNeil for personal injuries linked to blood clots while they were taking the patch.

Source: Andrew Bridges, “Warning added to birth control patch,” Associated Press, September 23, 2006.