Drugs Xagena
The FDA ( Food and Drug Administration ) has approved additional changes to the Ortho Evra Contraceptive Transdermal Patch label to include the results of a new epidemiology study 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.
Thromboembolism can lead to pulmonary embolism.
The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program ( BCDSP ) on behalf of Johnson and Johnson. The patch was studied in women aged 15-44.
These recent findings support an earlier study that also said women in this group were at higher risk for thromboembolism.
In September 2006, FDA revised the label for Ortho Evra to warn women of the risk of thromboembolism based on two epidemiology studies. One study showed that some women using the patch were at a two-fold greater risk of developing thromboembolism. The other study showed they were not at increased risk compared to women using birth control pill containing 30-35 micrograms of estrogen and the progestin Norgestimate.
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 thromboembolism. Women should discuss with their health care provider the possible increased risk of thromboembolism 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.
Source: FDA, 2008
XagenaMedicine_2008
