According to the latest research involving insurance claims data from about 34,000 women, the risk of blood clots occur more than twice as often as women who take oral contraceptives. The study appears in the February 2007 issue of Obstetrics and Gynecology.
Since the Ortho Evra patch was approved in 2001 and marketed in 2002, there have been numerous reports of users between the ages of 17 and 30 who have suffered blood clots, strokes and even fatal heart attacks.
In 2005, a study conducted by an independent panel of medical experts concluded that the Ortho Evra Patch triples a woman's risk of developing a fatal blood clot or deep vein thrombosis (DVT). It is estimated that the risk of death from Ortho Evra side effects resulting in blood clots or deep vein thrombosis (DVT) was three in every 200,000 women using the Ortho Patch. The risk of fatal blood clots from the oral birth control pill comparatively is one death in 200,000 women using an oral contraceptive.
In November 2005, the FDA approved updated labeling for the Ortho Evra patch to warn healthcare providers and users that this product exposed women to about 60 percent higher level of estrogen than most birth control pills.
Blood clots are life-threatening: they can lodge in the veins of the legs or lungs, and less frequently, in the arteries of the heart (heart attack) or brain (ischemic stroke). In 2004, about a dozen women died from clot-related complications; they were in their late teens and early 20's. Parents of one 14-year-old girl who died after using the Ortho Evra patch are suing Ortho-McNeil Pharmaceutical for failing to warn people sooner about serious side effects from using their birth control patch.
Why didn't the makers of Ortho Evra retool the patch to deliver less estrogen when they first knew of the link between blood clots and the Patch?