Ortho Evra Birth Control Patch Users Had Increased Risk Of Blood Clots

Large Study Shows Risk With The Patch Is Two Times Higher Than Observed In Women Using Birth Control Pill

(Posted by Tom Lamb at DrugInjuryWatch.com)

The February 2007 edition of the medical journal Obstetrics and Gynecology includes a study report which concludes that women who used the Ortho Evra birth control patch seem to be at double the risk of developing a dangerous blood clot in their veins as are women who use birth control pills, or oral contraceptives.

This study involved 49,000 women who used the Ortho Evra patch -- an Ortho-McNeil Pharmaceutical, Inc. and Johnson & Johnson product -- and 202,000 who used oral contraceptive pills between April 2002 and December 2004.

We get more details from a February 17, 2007 Reuters article reporting about this new Ortho Evra study:

Dr. Alexander M. Walker and colleagues, from i3 Drug Safety in Auburndale, Massachusetts, note that it was not known if users of the [Ortho Evra] patch system ran the same risk of stroke, heart attack and venous blood clots as users of oral contraceptives....

The researchers found that the occurrence of blood clots or "venous thromboembolism" in [Ortho Evra] patch users was 2.2-times higher than in [birth control] pill users: 40.8 vs. 18.3 cases per 100,000 women per year.

Because heart attacks and strokes were so rare, the researchers could not tell from their data if the risk of these outcomes was any different, statistically speaking, between the [birth control] pill and the [Ortho Evra] patch users.

As background, in November 2005 the FDA together with Ortho-McNeil and Johnson & Johnson announced a change for the Ortho Evra label, or package insert, to warn doctors and patients about a possible increased risk of so-called "thrombotic events" because of a higher average circulating estrogen levels in women wearing the Ortho Evra patch.