J&J TO ADD NEW STUDY RESULTS TO ORTHO EVRA LABEL

The FDA announced that the results of two epidemiology studies sponsored by Johnson & Johnson (J&J) will be added to the warning portion of the label for the birth control patch Ortho Evra.

The separate studies came up with conflicting results as to whether the patch increases women's risk of developing dangerous blood clots, so the agency has decided not to strengthen the warning, said Daniel Shames, acting deputy director at the CDER's Office of Drug Evaluation III. "We still believe the risk-benefit profile is appropriate for this particular contraceptive," he said.

The studies sought to evaluate the risk that women using Ortho Evra might experience venous and arterial blood clots. One study, conducted by the Boston Collaborative Drug Surveillance Program, found that the risk of nonfatal venous thromboembolism (blood clots) associated with the use of the Ortho Evra contraceptive patch is similar to the risk associated with the use of oral contraceptive pills containing 35 micrograms of ethinyl estradiol (an estrogen) and norgestimate (a progestin hormone). The other study, conducted by i3 Ingenix, showed "an approximate twofold increase" in the risk of venous thromboembolism in users of Ortho Evra, compared with users of norgestimate-containing oral contraceptives containing 35 micrograms of estrogen.