Johnson & Johnson

Venous thromboembolism is a blockage of an artery in the lungs by fat, air, a blood clot or tumor cells. Oral contraceptives, such as Yaz, Yasmin and the generic Ocella, put women at risk for blood clots. The patch is no exception. In the past few years, Johnson & Johnson settled several lawsuits filed against it from women who alleged that the contraceptive patch caused blood clots and other serious side effects due to heightened estrogen levels.

The transdermal patch includes the following warning: “Hormones from ORTHO EVRA® get into the bloodstream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use ORTHO EVRA® than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects. The risk of venous thromboembolic events (blood clots in the legs and/or the lungs) may be increased with ORTHO EVRA® use compared with use of birth control pills. Studies examined the risk of these serious blood clots in women who used either ORTHO EVRA® or birth control pills containing one of two progestins (levonorgestrel or norgestimate) and 30–35 micrograms of estrogen. Results of these studies ranged from an approximate doubling of risk of serious blood clots to no increase in risk in women using ORTHO EVRA® compared to women using birth control pills.”

The patch’s new label lowers the system’s odds ratio for venous thromboembolism risk from 2.5 (1.1-5.5) to 2.2 (1.2-4.0). This change additional 24 months of data from the i3 Ingenix Study and data from a new post-marketing study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP).

SOURCE: Ortho Evra and Blood Clots › FDA approves Ortho Evra’s new warning label

Leslie Niedner

Leslie cannot remember who first raised the question of whether Adrianna was on the birth control patch. But the suggestion sent her searching the Internet for answers. She quickly found dozens of other stories like Adrianna’s – of healthy young women on the Ortho Evra transdermal contraceptive patch who mysteriously suffered sometimes fatal heart attacks, strokes or blood clots.

“Why would they prescribe this?” Leslie asked the Boston Globe. The question is even more painful to ask, knowing that that thousands of lawsuits have mounted against Johnson & Johnson, makers of the Ortho Evra patch, by women who have been injured or died after using the patch. Johnson & Johnson has paid $70 million to settle the lawsuits.

The bad press has dropped sales of the patch by 75 percent, but the drug is still approved for use by the Food and Drug Administration. “It’s needlessly dangerous,” says Sidney Wolfe, director of the Health Research Group at Public Citizen, a consumer advocacy organization in Washington, during an interview with UPI.

The birth control patch was marketed to younger women because the weekly patches provide a more convenient alternative to daily birth control pills. However, those patches have been found to deliver far more estrogen than birth control pills, Those higher estrogen levels can double a woman’s risk of blood clots.

SOURCE: Ortho Evra and Blood Clots › Mother of Ortho Evra user asks why her daughter had to die