Ortho Evra
February 23, 2006Ortho Evra birth control patch users twice as vulnerable to blood clots, drugmaker-funded study shows
Women who use the Ortho Evra birth control patch (made by Ortho-McNeil, a subsidiary of Johnson & Johnson) double their likelihood of developing blood clots, compared with women taking oral birth control pills, according to interim results from a study funded by Ortho-McNeil.i3 Drug Safety, an Ingenix subsidiary, conducted the study. It compared the combined risk of heart attack, stroke and blood clots in the legs or lungs in women taking Ortho Evra with those who took oral contraceptive pills containing estrogen and norgestimate. While the study did not find a heightened combined risk for heart attack and stroke in women using Ortho Evra, they had twice the risk of blood clots as women who took the pill.
A separate study (also funded by Ortho-McNeil’s subsidiaries) comparing Ortho Evra users with pill users examined a database of 200,000 women and found the two groups to have a similar risk of blood clots. That study, conducted by the Boston Collaborative Drug Surveillance Program and published in the January 30 online edition of the journal Contraception, also found no increased risk for heart attack and stroke among women using Ortho Evra, but the data is still being evaluated.
Ortho-McNeil says the data from both studies has been given to the Food and Drug Administration. In November 2005, the agency warned that women who use the Ortho Evra birth control patch have a greater risk of suffering blood clots and other Ortho Evra side effects than previously stated because the patch exposes users to 60% more estrogen than do birth control pills. Women who used the Ortho Evra patch in 2004 were three times as likely as women using birth control pills to die or develop non-fatal blood clots.
Dr. Daniel Shames, director of the FDA’s Division of Reproductive and Urologic Drug Products, said that the results from the two Ortho-McNeil-funded studies, which link the Ortho Evra birth control patch to an increased risk of blood clots, are “preliminary” and expects no further regulatory action.