Stronger warning added to J&J's birth control skin patch

Birth control skin patches are used by millions of women to help prevent pregnancy. But a study, conducted by the Boston Collaborative Drug Surveillance Program, has linked the patches to an increased risk of serious blood clots.

Based on the shocking results of the new study, the US Food and Drug Administration late Friday revealed that women using the Ortho Evra birth control skin patch carry a risk of serious blood clots that form in the legs and lungs, a condition known as venuous thromboembolism.

The FDA also said that the risk is higher than the risk already recognized for the birth control pill, prompting Johnson & Johnson, the manufacturer of Ortho Evra birth control skin patch, to make changes to the labeling of the product.

The US health agency said it has approved changes to the labeling for the Ortho Evra Contraceptive Transdermal Patch, to better warn women and their doctors of the potential risk.

The warning about venous thromboembolism is not new on the Ortho Evra patch label, in fact it is mentioned on the product labeling since September 2006. The warning now includes wordings that women using the Ortho Evra Contraceptive patch are at higher risk of blood clots compared to those using birth control pills.

Women who use the patch will be exposed to about 60 percent more estrogen than if they were using typical birth control pills, FDA said. They face dramatically higher overall exposure to estrogen than those who use oral contraceptives, which contain 35 micrograms of estrogen. Higher estrogen exposure has been linked to the increased risk of side effects, including venous thromboembolism, in some women.

FDA said that Ortho Evra is indeed a safe and effective method of contraception when used according to the labeling that urges users with concerns or risk factors for serious blood clots to consult their doctors about using Ortho Evra versus other contraceptive options.

"For women that choose to use contraceptives, it is important that they thoroughly discuss with their health-care providers the risks and benefits involved," said Dr. Janet Woodcock, deputy commissioner for scientific and medical programs at the FDA.

The FDA has now ordered the results of the fresh study to go on the Ortho Evra patch label.

Made by Ortho-McNeil Pharmaceuticals, a division of Johnson & Johnson, the Ortho Evra Contraceptive Transdermal Patch was approved by the FDA in 2001.

The two most common manifestations of venous thromboembolism (VTE) are deep vein thrombosis and pulmonary embolism. Deep vein thrombosis or DVT involves the formation of a clot (thrombus) in the larger veins of the area. This clot may interfere with circulation, and may break off and travel through the blood stream (embolize). A resulting embolus can lodge in the brain, lungs, heart, or other area, causing severe damage to that organ.

Blood clots that form in the deep veins of the legs can become fatal if they not treated properly. The clot can break off and move to the heart and cause a heart attack, move to the lungs and cause a pulmonary embolism or to the brain and cause a stroke. If the clot is large enough, it can completely block that artery and cause death.