STUDY FUNDED BY JOHNSON & JOHNSON FINDS A TWO-FOLD INCREASE IN THE RISK OF THROMBOEMBOLISM AMONG ORTHO EVRA USERS
In a study prepared by I3 Drug Safety, a service company for the pharmaceutical industry, the authors found that women using the Ortho Evra birth control were more than twice as likely to suffer venous thromboembolisms than woman using oral birth control. There was not sufficient data to assess whether or not there were increased risks of strokes or heart attacks though increased incidence rates were noted. See “Venous Thromboembolism and Myocardial Infarction Among Transdermal Contraceptive Users” J. Alexander Cole, Obstet Gynecol 207; 109:339-46.
DID YOU KNOW THAT THE ORTHO EVRA PATCH MARKETD IN CANADA HAS A LOWER DOSE OF ESTADIOL DUE TO SAFETY CONCERNS?
November 10, 2005 – SOGC Statement
EVRA marketed in Canada has lower estrogen amounts than ORTHO EVRA in the US
On November 10, 2005, the US Food and Drug Administration (FDA) announced new prescribing information for the ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system) birth control patch.
The US prescribing information has been revised to include a warning that systemic exposure (area under the curve) of ethinyl estradiol (EE) is approximately 60% higher in women using ORTHO EVRA compared with women using an oral contraceptive containing EE 35Âµg. In contrast, peak concentrations for EE are approximately 25% lower in women using the patch.
A recent pharmacokinetic study comparing EVRA to an oral contraceptive containing 35Âµg EE and 250mgs norgestimate (CYCLEN) indicated that the exposure for EE and NGMN were comparable for EVRA and CYCLEN. It should also be noted that there has been no causal link identified between the higher level of estrogen from the US manufactured ORTHO EVRA patch and any increased risk of VTE.
The new prescribing information provided in the Unites States does not apply to the Canadian market as EVRA sold in Canada uses a different manufacturing process than the patch sold in the US. ORTHO EVRA marketed in the US has 0.75 mg EE vs. the Canadian EVRA patch which contains a lower amount of ethinyl estradiol (0.6 mg EE), producing estrogen levels comparable to 35Âµg pills.