Ortho Patch Study Data Re-confirms Risk of Clots

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Wednesday, January 30, 2008

PTINR.com Staff

Two label changes in two years confirms the risk of venous thromboembolism in patients using the patch.

The Food and Drug Administration (FDA) approved more stringent labeling of the Ortho Evra® Contraceptive Transdermal (Skin) Patch, commonly referred to as “the patch”. A new study revealed that the patch increases the risk of serious blood clots when compared to conventional birth control pills.1

The new label changes were made in response to an epidemiologic study conducted by the Boston Collaborative Drug Surveillance Program, in conjunction with Johnson and Johnson. The study included women between the ages of 15-44.1

The study demonstrated that Ortho Evra® specifically increases the risk of venous thromboembolism (VTE), a condition caused by the development of a blood clot. Venous blood clots can enter the pulmonary circulation and cause a more serious condition called pulmonary embolism (PE).

Revisions of the Ortho Evra® label were also made in 2006, in response to two earlier epidemiological studies. The results of these studies conflicted. One study showed up to a two-fold increased risk of developing VTE on the patch, while the other demonstrated an equivalent risk between the patch and conventional birth control pills containing 30-35 micrograms of estrogen.1

The FDA recommends that patients considering birth control consider the available 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 Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.”1

“Ortho Evra® is a prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. Because the hormones are processed by the body differently than hormones from birth control pills, women using the product will be exposed to about 60 percent more estrogen than if they were using typical birth control pills containing 35 micrograms of estrogen. Increased levels of estrogen may increase the risk of side effects, including VTE. Women should discuss with their health care provider the possible increased risk of VTE with Ortho Evra®, which is applied once a week, and balance this risk against the increased chance of pregnancy if women do not take their birth control pill daily.”1

Consumers can contact the FDA with questions about this or any other drug. Call the FDA’s Division of Drug Information at: 888-INFO-FDA (888-463-6332), or email to: druginfo@fda.hhs.gov.1

Patients who develop blood clots, including VTE and PE, may be placed on warfarin (Coumadin ®) to prevent further blood clot development. Warfarin patients monitor medication dosing with a blood test called a prothrombin time (PT) test, which is expressed as an international normalized ratio (INR). Studies have shown that more frequent INR testing increases the time patients are within their INR target range. “When monitored monthly, around 50% of patients remain within range, compared to 85% when monitored weekly”.2

Patients interested in home INR monitoring may call Quality Assured Services, Inc. for more information at: (800) 298-4515.