Increased Risk of Clotting



Ortho McNeil, a subsidiary of Johnson & Johnson and the manufacturer of the Ortho Evra birth control patch, originally claimed that the risk of developing blood clots as a result of using the Ortho Evra patch is no different from the blood clotting risk posed by the use of oral contraceptives. However, according to published reports, data obtained from the FDA pursuant to a Freedom of Information request suggest that the risk of clotting from the use of the Orho Evra patch is three times greater than the clotting risk posed by the use of oral contraceptives. Moreover, the data also suggest that the risk of dying from the use of the Ortho Evra patch is also three times greater than the risk of dying from the use of oral contraceptives. These observations are based upon data that was collected by Ortho McNeil and reported to the FDA prior to the FDA's approval of the Ortho Evra patch.

According to the Associated Press, the data indicates that "[I]f you are a woman taking the pill who doesn't smoke and is under 35, the chance that you are going to have a blood clot that doesn't kill you is between 1 and 3 in 10,000. Your risk of dying from a blood clot while using the pill is 1 in 200,000. By contrast, with the patch, the rate of nonfatal blood clots was about 12 out of 10,000 users during the clinical trials while the rate of deaths appears to be 3 out of 200,000."

On November 10, 2005, the FDA announced a revision to the labeling for the Ortho Evra birth control patch. The new labeling provides a warning that women who use the Ortho Evra birth control patch may be exposed to approximately 60% more estrogen than women who use oral contraceptives. Exposure to higher levels of estrogen carries an increased risk of developing blood clots that can lead to serious health consequences such as heart attack, stroke and pulmonary embolism.

On February 16, 2006, the manufacturer of the Ortho Evra® birth control patch disclosed the results of an unpublished epidemiological study supporting the belief that the use of the Ortho Evra® birth control patch poses a greater risk of developing blood clots than that posed by oral contraceptives. The recent study, funded by the manufacturer of the Ortho Evra® birth control patch, concludes that, when compared to oral contraceptives, the use of the Ortho Evra® birth control patch doubles the risk of developing venous thrombosis (blood clots and deep vein thrombosis). This increased risk is believed to be attributable to the transdermal hormonal delivery system that is unique to the Ortho Evra® birth control patch. The transdermal patch delivers estrogen directly into a woman’s blood stream whereas oral contraceptives provide estrogen through the digestive system. Absorption through the blood stream is greater and more rapid than absorption through the digestive system. 

On February 17, 2006, the FDA held a news conference to assure the public that the FDA is monitoring the results of this and other studies designed to study the risk of blood clots and other thromboembolic injuries (e.g. pulmonary embolism, heart attack, stroke, sudden death) and the use of the Ortho Evra® birth control patch. However, Daniel Shames, M.D., director of the FDA’s Division of Reproductive and Urologic Drug Products, said “At this time we do not plan on taking any specific regulatiry action based on these preliminary results.”

If you or a loved one has suffered a heart attack, stroke, sudden cardiac death, or a pulmonary embolism while using the Ortho Evra Patch and have questions about your legal rights, fill out our free case evaluation form.