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Ortho Evra Birth Control Patch: September 2006 Warning About Serious Blood Clot Risks

Ortho Evra Label Change By Johnson & Johnson Prompted By Results Of Two Studies

In September 2006 the FDA and Johnson & Johnson (J&J) -- the parent company of Ortho-McNeil Pharmaceutical -- announced that there would be changes made to the Ortho Evra label, or package insert.

According to a September 20, 2006 FDA MedWatch Alert, the Ortho Evra label, or package insert, was being changed as a result of new data from two studies which were intended to quantify the risk of developing a serious blood clot in a woman using the Ortho Evra skin patch in comparison to that of a woman using a traditional birth control pill.

Here are simple summaries of the two studies which prompted this Ortho Evra label change by J&J. The first study suggested that the Ortho Evra skin patch does not cause a blood clot risk any higher than that present for a woman using a birth control pill. The second study, however, concluded that, in comparison to the pill, the Ortho Evra patch produces almost double the risk of developing serious blood clots, or venous thromboembolism (VTE).

In more detail, from the September 2006 Ortho Evra MedWatch Alert:

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.

Simultaneous with issuing this MedWatch Alert, the FDA posted an Ortho Evra Questions and Answers page on its web site in an attempt to explain to patients the reasons for this Ortho Evra label change.

A September 20, 2006 Wall Street Journal article about the Ortho Evra warning being changed provided this explanation by the FDA about why the Ortho Evra label was being updated:

"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."

J&J had previously revised the Ortho Evra label in November 2005 for the purpose of putting on it an initial warning about a possible increased blood clot risk for woman who wore the birth control patch, sometimes simply called "the patch".

Read more on our Ortho Evra Information Page >>


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