January 18, 2008 – The U.S. FDA, the equivalent of the Saudi Food and Drug Authority approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include higher risk of developing venous thromboempolism (VTE).
The changes is based on results of a new epidemiological study by the Boston Collaborative Drug Surveillance Program (BCDSP) that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills.
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. Recommendations and Considerations that should be followed:
·For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved.
·Women with concerns or risk factors for thromboembolic events should talk with their health care provider about using Ortho Evra versus other contraceptive options.
·Woman wants to change from the Ortho Evra patch to a birth control pill, should talk to her health care professional. The health care professional will help her make this decision and select a different birth control option.
REPORT ADVERSE DRUG REACTIONS TO THE SAUDI FDA
The public and health professionals are encouraged to report adverse drug reactions the National Pharmacovigilance Center on the Internet at: