Ortho Evra Patch Label Change: Serious Blood Clot Risk Warning Increased

Results From Two Studies Prompt Action By FDA and Johnson & Johnson

In September 2006 the FDA and Ortho-McNeil Pharmaceutical -- a Johnson & Johnson (J&J) company -- announced changes to the Ortho Evra label, or package insert.

According to an FDA MedWatch Alert issued September 20, 2006 about Ortho Evra the prescribing information was being revised due to new data from two studies which evaluated a woman's risk of developing a serious blood clot while using the Ortho Evra skin patch compared to using a traditional birth control pill.  In more detail:

The first study found that the risk of non-fatal venous thromboembolism (VTE) associated with the use of Ortho Evra contraceptive patch is similar to the risk associated with the use of oral contraceptive pills containing 35 micrograms of ethinyl estradiol and norgestimate. The second study found 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.  Although the results of the two studies differ, the results of the second study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women.

To make the reasons for this Ortho Evra label change more understandable to patients, in conjunction with its MedWatch Alert the FDA posted an Ortho Evra Questions and Answers page on its web site.

Essentially, one study suggests the Ortho Evra birth control patch does not cause a blood clot risk higher than a birth control pill, whereas the other study suggests that Ortho Evra produces an almost two-fold increase in the risk of developing serious blood clots, or venous thromboembolism (VTE).  Preliminary results from these two studies had been released in February 2006, and the updated findings released in September 2006 were similar.

According to a September 20, 2006 Wall Street Journal article about this Ortho Evra warning update:

"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 FDA said. "The label has recommended and continues to recommend that women with concerns or risk factors for thromboembolic disease talk with their health-care provider about using Ortho Evra versus other contraceptive options."

The FDA and J&J previously revised the Ortho Evra label in November 2005 to warn of a possible increased blood clot risk.

(Posted by: Tom Lamb)