Ortho Evra Contraceptive Patch Increases Risk of Blood Clots. According to a study published this month in the journal Obstetrics & Gynecology, women who use contraceptive patches, such as Ortho Evra, may be more than twice as susceptible to blood clotting as women who take oral contraception. The study was conducted by researchers at the i3 Drug Safety group.
The study looked at more than 98,000 women who’ve used transdermal (patch) contraception and compared them with more than 250,000 women who’ve used oral contraception; the median age was 25. According to the report, “There was a more than two-fold increase in the venous thromboembolism [blood clot] rate among transdermal contraceptive system users compared with oral contraceptives users.” Incidence of stroke and myocardial infarction was too low to produce any meaningful statistical connection.
Ortho-McNeil, makers of the controversial Ortho Evra birth-control patch, continues to deal with significant legal challenges. New York firm Parker & Waichman, LLP, announced in November that it had filed suit in the Superior Court of New Jersey on behalf of a 26-year-old woman who had suffered pulmonary emboli and will be forced to remain on a regimen of anticoagulent medication. The new suit marked the 100th filed by the firm in cases related to the patch.
43 Women Brought a Suit Against Ortho-McNeil
Last fall, 43 women brought a suit against Ortho-McNeil, a subsidiary of Johnson & Johnson, and San Francisco-based distributor McKesson Corp., alleging that use of the Ortho Evra patch has led to blood clots and other serious health problems. In a separate complaint, plaintiffs want to hold the company responsible for the death of an otherwise healthy 25-year-old woman, Kelly Bracken of Maryland, who suffered fatal blood clots in her lungs and legs after using Ortho Evra. Roughly 400 women have now filed suit against the pharmaceutical company in complaints related to the safety of the patch.
The researchers at i3, a unit of Ingenix, relayed their results to the FDA last September, which led to the institution of new label warnings for the patch. Plaintiffs in the pending suits, as well as some watchdog groups and medical professionals, claim that Ortho-McNeil failed to undertake a comprehensive investigation of the safety of the drug and may have withheld or downplayed potentially damaging information about its side effects during the FDA approval process.
Ortho Evra was approved by the FDA in 2001. According to Parker & Waichman, “Evidence shows that the risk of blood clots, heart attack, and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills…. As of November 2005, the FDA had logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths were associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.”