FDA tightens warning on J&J's Ortho Evra patch

The US Food and Drug Administration has tightened safety warnings on Johnson & Johnson's Ortho Evra (norelgestromin and ethinyl estradiol) contraceptive. The label of the transdermal birth control patch now includes the results of a new epidemiology study that found that users were at higher risk of developing serious blood clots, also known as venous thromboembolism, than women using birth control pills.

The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of US health care major J&J. The patch was studied in women aged between 15 to 44 years. These recent findings support an earlier study that also said women in this group were at higher risk for VTE. "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, the FDA's Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer, who is also Acting Director of the Center for Drug Evaluation and Research.

In September 2006, the agency revised the label for Ortho Evra to warn women of the risk of VTE based on two epidemiology studies. One study, conducted by i3 Ingenix, showed that some women using the patch were at a two-fold greater risk of developing VTE. The other study, conducted by BCDSP, showed they were not at increased risk compared to women using birth control pills containing 30mcg-35mcg of estrogen and the progestin norgestimate. The FDA stressed that Ortho Evra is "a safe and effective method of contraception when used according to the labeling," but recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using it rather than other contraceptives.