The label now includes 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. VTE can lead to pulmonary embolism. The label changes are based on a study of women between 15 and 44 years old that was conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. These recent findings support an earlier study that also said women in this group were at higher risk for VTE.

In September 2006, FDA revised the Ortho-Evra label to warn women of the risk of VTE based on two epidemiology studies. One study, conducted by i3 Ingenix, showed some women using the patch were at a two-fold greater risk of developing VTE. The other study, conducted by BCDSP, showed they weren’t at increased risk compared to women using birth control pills containing 30-35 micrograms of estrogen and the progestin norgestimate. This is the FDA statement.