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Ortho Evra Warning

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CNN has an important story users of Ortho Evra, a popular once-a-week birth control patch. Essentially, Ortho McNeil released a warning on Thursday that the patch exposes users to more estrogen and increases the risk of blood clots. “Thursday’s warning comes four months after reports that patch users die and suffer blood clots at a rate three times higher than women taking the pill.”



From their own website, they give a new warning in bold:

You will be exposed to about 60% more estrogen if you use ORTHO EVRA than if you use a typical birth control pill containing 35 micrograms of estrogen…Some women should not use the Patch, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.

My girlfriend used to use the patch, because of its convenience, but was experiencing some bad side effects and so switched to something else. 60% is a lot of percent to be off by.

Is this going to be a trend? Just as we had accounting “irregularities” with Enron and Worldcom, are we going to be seeing more medical oversights (Vioxx, now Othro Evra)?

This particular bit from CNN’s story infuriates me:

…an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was “too high a chance that study may not produce a positive result for Evra” and there was a “risk that Ortho Evra may be the same or worse than Ortho-Cyclen.”

It’s bullshit.

(I linked this to Outside the Beltway)

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6 Responses to “Ortho Evra Warning”

  1. Cap says:

    woah. 60%?

    they sure as hell didnt mention that in those ads.

  2. jim says:

    And if you look at their main homepage, it’s not even shown… you’ll have to click on “New Important Labeling Information” to actually find it.

  3. denon says:

    I’m beginning to wonder if the folks at the FDA have forgotten who their boss is. Maybe they’re getting more bribe money than salary, and think they work for the medical industry.

    These guys really need to get on their toes – for the cost of this stuff, they could at least do their homework. The FDA should also be especially conscientious of this kind of thing, with such a huge number of users.

  4. jac says:

    so how much estrogen is in the patch exactly 60% more than 35 mcgm or 60% more than its original 20 mcgm? They aren’t very clear as to how much is in there. I recently got a prescription for the patch cuz I thought it would be convenient to be on a patch instead of takin a pill everyday..now this happens..great.

  5. denon says:

    I don’t think the amount in the patch is exactly 60% higher, I think more is absorbed directly into the bloodstream via this method. When taking a pill, your digestive system “wastes” a lot of it, and it’s never absorbed. The whole scandal, is that they weren’t reporting the proper (higher) percentage being absorbed with the patch.

  6. jim says:

    Yeah, Denon is right. Also, another part of the scandal was that they didn’t do some studies because they feared an unfavorable result…


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