Ortho Evra
November 10, 2005FDA updates Ortho Evra label to reflect clot risk
The Food and Drug Administration has announced a plan to update the warning label for the Ortho Evra birth control patch. The new warning states that Ortho Evra users receive a much greater dose of hormones than do users of birth control pills. Because the hormones in the Ortho Evra patch can cause blood clotting, this may put women using the patch at a higher risk for strokes, heart attacks and other birth control patch side effects.The increased dose of the hormones estrogen and progestin that Ortho Evra users receive is caused by the way in which the patch works. While the hormone dose in the birth control patch is roughly the same as in birth control pills, the hormones in Ortho Evra do not have to pass through the stomach and liver before being absorbed into the bloodstream. Because of this, Ortho Evra users receive a 60% higher dose of estrogen than do birth control pill users.
The risk of birth control patch side effects associated with increased estrogen exposure has been backed up in several recent studies. A report by the Associated Press in July 2005 found that users of the Ortho Evra patch suffer blood clots and die at a rate three times higher than for birth control pill users. The report also found that more than a dozen women had died by 2004 due to serious birth control patch side effects. Many more survived blood clots, stroke, heart attack or other Ortho Evra side effects.
Several women who used the patch have filed Ortho Evra lawsuits against Johnson & Johnson and Ortho-McNeil (maker of the birth control patch) because of their birth control patch side effects. Documents from these lawsuits have added to the growing evidence against the Ortho Evra patch. Ortho-McNeil had studied the FDA’s death and injury reports for Ortho Evra and found that users of the patch face a higher risk of blood clots or birth control patch deaths than do users of the pill.
Furthermore, an internal memo uncovered during one birth control patch lawsuit found that Ortho-McNeil refused to fund a study in 2003 comparing the Ortho Evra patch with its Ortho Tri-Cyclen pill because there was “too high a chance that study may not produce a positive result for Evra” and that the risk of Ortho Evra side effects would be greater than with the pill.
Many of the women who suffered birth control patch injuries after using the Ortho Evra patch say that they are shocked that Ortho-McNeil may not have properly informed consumers about the risk of birth control patch side effects associated with Ortho Evra. Jennifer Cowperthwaite, who used the Ortho Evra patch in 2003, suffered severe blood clots that still cause her breathing problems. She says that knowing about the risk of birth control patch side effects associated with the Ortho Evra patch may have caused her to rethink her decision to use the patch. “I wish I had known,” she says. “It’s quite likely I would never have used it.”
Kathleen Thoren died from blood clots in her brain which a coroner ruled were the result of Ortho Evra side effects. Her sister, Erika Klein, says that Ortho-McNeil should be required to inform the public about birth control patch problems like those experienced by Kathleen. “Women have the right to know the true risks and make their decisions based on that information,” she says. “No one should have to go through what my sister went through.”