FDA calls for label revision on Ortho Evra birth-control patch
The FDA announced a revision to the labeling for the Ortho Evra birth-control patch, warning that women taking the drug may be exposed to 60% more estrogen than if they were taking a typical 35 microgram estrogen birth-control pill, levels that could lead to blood clots and strokes in patients.
The label change will include a new bolded warning about the higher exposure to estrogen, the agency said.
A spokeswoman for Ortho-McNeil Pharmaceuticals, the Johnson & Johnson subsidiary that manufactures the drug, told the Associated Press that the warning speaks for itself and that the companies have been cooperating with the FDA, which is distributing the warning to
In July, 10 women filed a lawsuit against J&J's Ortho-McNeil claiming the patch caused them to suffer strokes and blood clots. The lawsuit alleges the patch is "defectively designed" and "unreasonably dangerous."
In September the consumer advocacy group Public Citizen added Ortho Evra to its list of allegedly dangerous medicines, arguing that there is "no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood and equally effective oral contraceptives."