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.

Comments

[Tom Lamb]

This is an issue better-suited for your doctor.

As a lawyer, I am not able to answer medical questions like this one.

Thanks for reading Drug Injury Watch.

Tom Lamb

[sally]

i am an 18 year old who just started using the patch.i do alot of swimming and i noticed that the patch doesnt stick on like it says it should.it peels off at the edges and water gets in, does that mean im at risk getting pregnant?

[Tom Lamb]

Thank you for sharing this serious side effect information as regards your use of Ortho Evra.

Unfortunately, this birth control patch is still on the market and there continues to be reports of pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic strokes (CVA), and heart attacks (MI) associated with Ortho Evra use.

As you may know, personal injury lawsuits involving Ortho Evra have been filed for people with medical conditions such as yours. If you are interested in learning more about the ongoing Ortho Evra litigation, you should feel free to contact me either by email (druginjury@gmail.com) or by phone (800-426-9535).

Tom Lamb

[Vickie Boyd]

Just to let anyone interested know. I am a 37 year old non smoker. Last October I suffered blood clots in both of my lungs. The one in my left lung blocked 85% of the blood flow. I am lucky to have survived. I was using the Ortho-Evra patch at the time. Glad to hear it is no longer on the market.

[Tom Lamb]

Thank you for your comment.

As I am not a medical doctor, I am not able to answer your question about what could have happened to your grandchild.

In my experience handling drug injury cases, I have not heard of these conditions being associated with Ortho Evra but that is not to say that they are unrelated (see prior statement).

If you learn of any connection, please let us know.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Barbara]

I have a granddaughter who will turn three next week. She was conceived while her mother was on a birth control patch. She has had two sinus surgeries, two kidney surgeries, and will have surgery this week for a double hernia. If the birth control patch didn't do what it was supposed to do, what did it do to my granddaughter?