Ortho-McNeil is conducting additional studies to gauge the risk of developing serious blood clots in women using the Ortho Evra transdermal contraceptive versus typical oral contraceptives, FDA said in a Nov. 10 press release.

A bolded warning was added to Ortho Evra (norelgestromin/ethinyl estradiol) labeling Nov. 10 to report that the patch yielded greater overall exposure to the contraceptive hormones than oral products.

"The pharmacokinetic (PK) profile for the Ortho Evra patch is different from the PK profile for oral contraceptives in that it has higher steady state concentrations and lower peak concentrations," the warning states.

Concentrations of ethinyl estradiol (EE) "are approximately 60% higher in women using Ortho Evra compared with women using an oral contraceptive containing EE 35 ug. In contrast, peak concentrations for EE are approximately 25% lower in women using Ortho Evra."

"However, it is not known whether there are changes in the risk of serious adverse events based on the differences in pharmacokinetic profiles of EE in women using Ortho Evra compared with women using oral contraceptives," the warning concludes.

The addition of the warning was based on an FDA and Ortho-McNeil analysis that directly compared levels of estrogen and progestin hormones in users of Ortho Evra and typical oral contraceptives, the agency said.

"In general, increased estrogen exposure may increase the risk of blood clots," FDA added.

Questions about the safety of Johnson & Johnson's transdermal drug delivery systems were raised in July after press reports that Ortho Evra may have contributed to approximately 12 deaths in 2004 due to blood clots. The company asserted that there are "no higher safety concerns with the use of a patch than there would be with oral administration" (¹ Also see "J&J Defends Duragesic, Ortho Evra Patches" - Pink Sheet, 19 July, 2005.).

Updated labeling for Ortho Evra, which was approved Nov. 10, 2005, also includes a new subsection comparing pharmacokinetic information for transdermal versus oral contraceptives.

Ortho-McNeil said that the labeling changes will be "communicated to the medical community via a Dear Healthcare Professional Letter."

-Christopher Hollis

Ortho-McNeil Conducting Additional Studies To Assess Ortho Evra Blood Clotting Risks

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