Johnson & Johnson’s Ortho Evra birth control patch now comes with a new warning that users could face twice the risks of blood clots in their lungs and legs compared with birth control pills.[1] The FDA announced the update to the Ortho Evra birth control patch label on September 20, 2006, to include the results of two separate studies sponsored by Johnson & Johnson that were designed to evaluate the risk of serious side effects like blood clots when using the Ortho Evra birth control patch. One of the studies found that women using the Ortho Evra birth control patch had twice the risk of developing blood clots (strokes) as women using a different, commonly prescribed oral contraceptive.[2] The second study purported to uncover no increased risk of non-fatal venous thromboembolism (VTE), which includes blood clots that occur in the legs’ deep veins known as deep vein thrombosis (DVT) and blood clots that travel to the lungs known as pulmonary embolism (PE).[3] The FDA has indicated that even though the results of the two studies are conflicting, the results of one of the studies “support FDA’s concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women.”[4]
The study that demonstrated an increased risk for blood clots among Ortho Evra birth control patch users was based on review of 500,000 electronic health care claims and patient charts. The final results were consistent with preliminary results released in February, and the recent release of the study prompted the FDA to require Johnson & Johnson to update the Ortho Evra birth control patch warning label to include information from the two studies about increased risk of blood clots. In addition, the FDA has requested longer follow-up of the studies to evaluate for VTE, heart attack, and stroke risk among Ortho Evra birth control patch users. The FDA last November approved a revision to the Ortho Evra birth control patch label that warned doctors and patients that the patch exposes women to 60 percent more estrogen than a typical birth control pill containing 35 micrograms of estrogen.
Johnson & Johnson’s recent SEC report filed in August 2006 indicated that there are approximately 500 claimants who have filed lawsuits or made claims regarding injuries resulting from their use of Ortho Evra birth control patch.[5] Women with concerns or risk factors for thromboembolic (blood clotting) disease may want to talk with their health care provider about using the Ortho Evra birth control patch versus other contraceptive options.
Lawyers at Robins, Kaplan, Miller & Ciresi L.L.P. are currently investigating claims on behalf of individuals who allege that they or their loved ones were injured or died due to events caused by the Ortho Evra birth control patch. If you or someone you know has been injured or killed by a blood clot while using the Ortho Evra birth control patch and you wish to consult with a lawyer who handles Ortho Evra birth control patch cases, please call Tara Sutton at 612.349.8577. You can also send an e-mail by clicking on this link: contact us.
[1] Full U.S. Prescribing Information for Ortho Evra, revised Sept. 2006, available at http://www.orthoevra.com/html/pevr/full_prescribing.jsp?.[2] I3 Drug Safety, The Risk of Venous Thromboembolism, Myocardial Infarction, and Ischemic Stroke Among Women Using the Transdermal Contraceptive System Compared to Women Using Norgestimate-containing Oral Contraceptives with 35 mcg Ethinyl Estradiol, June 2006 (study unpublished with data on file at Johnson & Johnson).
[3] S.S. Jick, J.A. Kaye, S. Russmann & H. Jick, Risk of Nonfatal Venous Thromboembolism in Women Using a Contraceptive Transdermal Patch and Oral Contraceptives Containing Norgestimate and 35 mcg of Ethinyl Estradiol, 73 Contraception 223-28 (2006).
[4] U.S. Food and Drug Administration, Questions and Answers: Ortho Evra (norelgestromin/ethinyl estradiol), available at http://www.fda.gov/cder/drug/infopage/orthoevra/qa20060920.htm.
[5] Johnson & Johnson, Quarterly Report (Form 10-Q), at n.12 (Aug. 8, 2006), available at http://www.shareholder.com/Common/Edgar/200406/200406-06-111/06-00.pdf.
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