The FDA ( Food and Drug Administration ) has announced an update to the Ortho Evra label with the results of two separate epidemiology studies sponsored by Johnson and Johnson.

These two epidemiology studies were conducted to evaluate the risk of developing a serious blood clot in women using Ortho Evra compared to women using a different, commonly prescribed, oral contraceptive.
Concern about this risk was originally based on reports of serious blood clots to FDA and to the sponsor that suggested that Ortho Evra may have a greater risk for venous thromboembolism ( VTE ), at least in some women, compared to oral contraceptives.

The results of the two studies are different.

The first study was conducted by the Boston Collaborative Drug Surveillance Program. This study found that the risk of non-fatal VTE events 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 second study, which also included patient chart review, was conducted by another group of investigators ( i3 Ingenix ). Results of this second case-control study show an approximate 2-fold increase in the risk of medically verified VTE events in users of Ortho Evra compared to users of Norgestimate-containing oral contraceptives containing 35 micrograms of estrogen.
Longer follow-up for venous thromboembolism, myocardial infarction and stroke, has been requested by FDA.

Even though the results of the two studies are conflicting, the results of the second epidemiology study support FDA’s concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women. The label has recommended and continues to recommend that women with concerns or risk factors for thromboembolic disease talk with their healthcare provider about using Ortho Evra versus other contraceptive options.

Source: FDA, 2006


XagenaMedicine2006