        | ||||||||
    Medication Adverse Effect Alert September 26, 2006 MEDICATION: ORTHO EVRA
Event Description: The FDA announced that of the 2 recent epidemiological studies conducted evaluating the risk of a serious blood clot in women using Ortho Evra compared to using an oral contraceptive, the first study show similar risk while the second study showed that the Ortho Evra group had a 2-fold increase in venous thromboembolism (VTE) over the oral contraceptive group. The comparison oral contraceptive in both studies contained 35mcg of ethinyl estradiol and norgestimate (a progestin hormone). Even though the results of the studies are conflicting, the FDA has expressed concern for the increased potential of Ortho Evra to cause VTEs in at risk women and has determined that the label warning be updated to include the results of both studies. Proposed Mechanism of Action: Pharmacokinetic studies suggests that women using Ortho Evra have increased exposure to estrogen in comparison to those taking oral contraceptives containing norgestimate and 35mcg of ethinyl estradiol. These studies indicate that the Ortho Evra group has a higher steady state concentration for ethinyl estradiol with the AUC and average blood level of ethinyl estradiol in the Ortho Evra users being 60% higher then the oral contraceptive users. This increased exposure to estrogen with Ortho Evra may lead to a higher risk of a VTE event. Recommendations: This new information should be taken into consideration when deciding on a contraceptive product. There is now additional evidence that suggests there may be an increased risk of a VTE event when using the Ortho Evra patch versus an oral contraceptive due to the possible increased in estrogen exposure for patch users. Further Implications: The FDA has requested a longer follow-up for VTE, heart attack and stroke. More information will be forthcoming.
|
||||||||
     |