A new black box warning has been added to the safety label of Johnson & Johnson’s birth control patch Ortho Evra (norelgestromin/ethinyl estradiol), alerting consumers that women aged 15-44 who use the patch may be at greater risk for life-threatening blood clots compared to women of the same age who take oral contraceptives. The boxed warning also informs users that cigarette smoking while using the patch puts them at greater risk for heart attacks.
While the boxed warning regarding cigarette smoking and cardiovascular risk is consistent with the current labeling for other combination hormonal contraceptives, the boxed warning for blood clots was recently upgraded from the Warnings section to the Boxed Warnings section. A black box warning is the strongest warning the FDA requires and is reserved for products that carry a significant risk of serious or even life-threatening side effects.
The new boxed warning states that the risk of venous thromboembolism (VTE), or blood clots, ranged from 1.2 to 2.2, and that one of the studies on which that ratio is based found a statistically significant increased risk for VTE for current users of Ortho Evra.
The VTE risk with the Ortho Evra transdermal patch was first added to the Warnings section of the product’s safety label in May 2010. New studies led the Food and Drug Administration (FDA) to require Johnson & Johnson to upgrade the warning to the strongest available.
Johnson & Johnson is facing more than 500 lawsuits from women or their families who have suffered heart attacks, strokes and sudden death while using the Ortho Evra birth control patch.