The Food and Drug Administration has announced an update to the warning label of the Ortho Evra birth control patch. The new label warns that users could face twice the risk of blood clots and other serious birth control patch side effects, compared with users of birth control pills. The FDA data were based on the results of two recent studies that analyzed the risk of blood clots, heart attack, stroke and other birth control patch side effects in women who used the Ortho Evra patch. Both studies were conducted by Johnson & Johnson, parent company of Ortho-McNeil.

The first study found that users of the Ortho Evra birth control patch faced twice the risk of side effects, compared with users of birth control pills. Because the blood clots that form after use of the Ortho Evra birth control patch can lead to other serious side effects—including stroke, heart attack and other birth control patch injuries—Ortho Evra patch users are also at risk for other serious birth control patch side effects.

A second study also examined by the FDA found no increased risk of deep vein thrombosis among users of the Ortho Evra birth control patch. However, the conclusive data from the first study, combined with an alarming number of cases of birth control patch side effects among Ortho Evra users, compelled the FDA to order an update to warn women about the Ortho Evra birth control patch side effects that they face. In addition, the FDA has called for follow-up studies in order to further examine the health risks posed by the Ortho Evra birth control patch.

The new change to the warning label of the Ortho Evra birth control patch is the second to be ordered by the FDA since it was released in 2002. In November 2005, the FDA ordered the first revision after a study found that women using the Ortho Evra birth control patch were exposed to 60% more estrogen than those using birth control pills. Because estrogen is a known coagulant, this increased exposure places women at a much greater risk of blood clots and other Ortho Evra birth control patch side effects.

So far, about 500 women have filed Ortho Evra birth control patch lawsuits against Johnson & Johnson and Ortho-McNeil. Despite the number of Ortho Evra lawsuits and numerous studies warning of its birth control patch side effects, neither Johnson & Johnson nor the FDA has yet ordered an Ortho Evra recall.