According to report published in the February 2007 edition of The Journal of Obstetrics and Gynecology, women using the Ortho Evra contraceptive patch experience a 2.2 times higher incidence of deep venous thrombosis than women using oral contraception of the same dosage. The study compared 49,000 women using the patch to 200,000 who used oral contraception between April 2002 and December 2004.

Pulmonary embolism, a possible result of deep venous thrombosis, occurs when a peripheral blood clot comes loose and is carried back through the arteries to lodge in the blood vessels of the lungs. Pulmonary embolisms cause respiratory distress and, if large enough, can cause sudden death.

Six Colorado women have said they experienced blood clots while wearing the patch and are now filing personal injury lawsuits as a result. Three of the women developed pulmonary embolisms. All six stated they were not informed about the risks of deep venous thrombosis associated with the Ortho Evra patch.

In a recent claim for wrongful termination, Dr. Joel Lippman, former chief medical officer with Ortho-McNeil, a subsidiary of Johnson & Johnson and manufacturer of the Ortho Evra patch, said he had warned the company the patch could cause serious health problems in women. Johnson & Johnson has denied Lippman’s assertions.

Dr. Lippman said the patch “released dangerously high levels of estrogen into patients.” His complaint also stated that he advised Ortho-McNeil that the company should “conduct further research to understand the impact of the hormones released by the patch.” Lippman said that Ortho-McNeil disregarded his concerns and launched the product.

Last September, the FDA required Ortho-McNeil to provide better warnings to consumers about the risks of deep vein thrombosis.

Sources: “Contraceptive patch may raise blood clot risk,” Reuters Health, February 19, 2007; J. Alexander Cole, et.al, “”Venous Thromboembolism, Myocardial Infarction, and Stroke Among Transdermal Contraceptive System Users(abstract),” Journal of Obstetrics and Gynecology 109 (February 2007); “Exclusive: Women Claim Birth Control Patch’s Risks Undisclosed,” DenverChannel.com, February 9, 2007.