On September 20, 2006, results of a new study were released that confirmed previous studies showing an increased risk of blood clots associated with the use of Ortho Evra versus oral contraceptives. The study found that women using Ortho Evra were twice as likely to develop blood clots as those using oral contraceptive pills. As a result, the FDA has asked Ortho McNeil Pharmaceuticals, a division of Johnson and Johnson, to update the safety label on Ortho Evra to warn users about the risk of blood clots, heart attacks and strokes.
In 2005, the FDA stated that women using Ortho Evra are exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. It is believed that the difference in exposure is related to the delivery mechanism of the birth control patch. Hormones in birth control pills are partially diluted by the digestive system. However, hormones in Ortho Evra are absorbed directly into the blood stream, which causes a higher concentration of the medication to enter a patient’s body. It is believed that high levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries.
Approximately 4 million women have used the Ortho Evra Patch since it went on sale in 2002. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. FDA records obtained by the Associated Press showed that seventeen patch users between the ages of 17 and 30 suffered fatal heart attacks, blood clots and possible strokes since August 2002.
The first fatality publicly blamed on the Ortho Evra patch was in April 2005, when a Manhattan fashion student collapsed in a New York City subway station. An autopsy found that a blood clot had moved into the victim’s lung, and the medical examiner ruled that the clot was a side effect of Ortho Evra. The news of this young woman’s death became front page headlines throughout New York.
The manufacturers of Ortho Evra have aggressively marketed the patch as a convenient alternative to oral birth control pills. The drug’s original safety label stated that the patch’s health risks were similar to those related to oral contraceptives, even though a recent whistle-blower suit alleges that the company was well aware that the birth control patch could cause high rates of blood clots.
Former Johnson and Johnson Chief Medical Examiner Dr. Joel Lippman recently blew the whistle on his old company. Lippman claims that during 15 years in high-ranking medical positions at Johnson and Johnson, the company repeatedly released or refused to recall dangerous products to which he objected, including the Ortho Evra birth control patch. In a whistle-blower suit brought against his former employer, Lippman claimed, The clinical research had revealed that the estrogen dose released by the Evra patch as a means of birth control may increase the risk of deep venous thrombosis and pulmonary embolisms.
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