Ortho Evra
April 1, 2006Manufacturer issues new Ortho Evra side effects warning
Ortho-McNeil, maker of the Ortho Evra birth control patch, says that users face an elevated risk of birth control patch side effects compared with users of traditional birth control pills. The company says that because the Ortho Evra birth control patch delivers a 60% higher dose of estrogen than does the pill, users are more likely to suffer Ortho Evra side effects such as blood clots, heart attack and stroke.The increased risk of side effects is due to how the Ortho Evra patch delivers hormones into the bloodstream. While the estrogen in birth control pills must first pass through the stomach and liver before it makes its way into the blood, the hormones released by the Ortho Evra birth control patch go directly through the skin and into the bloodstream. So although the dose of medication is the same for the pill and the Ortho Evra birth control patch, users of the patch receive 60% more hormones than do women who take the pill.
Because of this increased dose of estrogen, Ortho Evra users face an alarmingly higher risk of birth control patch side effects than do users of the pill. A July 2006 study found that three times as many Ortho Evra users died or suffered strokes, compared with users of the pill. Because of this increased risk, many women have already filed Ortho Evra lawsuits against Ortho-McNeil or its parent company, Johnson & Johnson, because of their birth control patch injuries.
However, documents that have come to light in these Ortho Evra birth control patch lawsuits may place the risk of injuries from birth control patch side effects even higher. Ortho-McNeil analyzed the Food and Drug Administration’s reports on Ortho Evra birth control patch injuries and deaths, and found them to be even higher than the July 2006 study indicated.
Other papers uncovered in the Ortho Evra birth control patch lawsuits found that Ortho-McNeil refused to fund a study in 2003 comparing the risk of Ortho Evra side effects with those of its Ortho Cyclen birth control pill. An internal memo written by a company employee said that Ortho-McNeil had declined to conduct the study of birth control patch side effects because “there was too high a chance that the study may not produce a positive result for Evra.” The memo even speculated that the risk of Ortho Evra side effects may be “worse than Ortho Cyclen.”