Label Warning for Ortho Evra Patch:The FDA has updated the label on the Ortho Evra Contraceptive Patch to include the results of an epidemiology study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The researchers found that users of the birth control patch were at higher risk of developing serious blood clots, known as venous thromboembolism, than women using combination birth control pills. The findings of this research support an earlier study that also revealed that women in this group were at higher risk for venous thromboembolism.
Included in January 2008 Label Update:The new labeling now includes these results in addition to supplementary information on the risk of venous thromboembolism in Ortho Evra Patch users in one of the original studies (based on 17 months of data on new cases). The updated label is in addition to the bolded warning added to the patch label in September 2006.
The FDA says it believes the patch to be a safe and effective contraceptive method when the labeling is followed and recommended that women who are at risk for serious blood clots should discuss the use of the Ortho Evra Patch versus other birth control options with their health-care providers.
The January 2008 Study:The Boston Collaborative Drug Surveillance Program studied Ortho Evra patch use in women aged 15-44. The research measured the risk of non-fatal venous thromboembolism among users of the birth control patch to the risk among users of oral contraceptives that contained 30 mcg of ethinyl estradiol and the progestin levonorgestrel. The results uncovered that there was an approximate two-fold increase in the risk of venous thromboembolism among the Ortho Evra Patch users.
Bolded Warning Label Update (September, 2006):The FDA included a bolded warning specifically stating that women who use the Ortho Evra Patch are exposed to about 60% more total estrogen in their blood than if they were taking a birth control pill containing 35 mcg of estrogen. The FDA explains because the hormones are processed by the body differently than hormones from birth control pills, women using the patch will be exposed to a higher percentage of estrogen. Increased levels of estrogen may increase the chances of side effects, including venous thromboembolism.
More on the September 2006 Label Update:The FDA, therefore, changed the Ortho Evra label in September, 2006 to warn women of venous thromboembolism based on the results of two epidemiologic studies sponsored by Johnson and Johnson. Whereas one study, revealed that some women using the patch were at a two-fold greater risk of developing venous thromboembolism, the other study concluded that Ortho Evra Patch users were not at increased risk compared to women using birth control pills containing 30-35 mcg of estrogen and the progestin norgestimate.
The November 2005 Label Update:The FDA added information to the Ortho Evra Conytaceptive Patch label in November 2005; at this time, the FDA warned about the increased exposure to estrogen (based on drug blood levels) seen in women using the birth control patch compared with oral contraceptives that contained 35 micrograms of ethinyl estradiol.
Source: FDA. (2008, Jan.). Ortho Evra (norelgestromin/ethinyl estradiol) Information. Accessed 1/28/08.
FDA. (2008, Jan.). Ortho Evra (norelgestromin/ethinyl estradiol) Information. Accessed 1/28/08.