Ortho Evra has a significantly worse safety profile than the pill

I wish I could say this suprised me, but it appears as though Ortho McNeil's birth control patch, Ortho Evra, has a higher rate of stroke & blood clots (deep vein thrombosis that can lead to life-threatening/fatal emboli in the heart, lung and/or brain) than the birth control pill.

The women who died were young and apparently at low risk for clots — women like Zakiya Kennedy, an 18-year-old Manhattan fashion student who collapsed and died in a New York subway station last April. Or Sasha Webber, a 25-year-old mother of two from Baychester, N.Y., who died of a heart attack after six weeks on the patch last March.

Some doctors, reviewing the Food and Drug Administration reports at the request of The AP, were alarmed. “I was shocked,” said Dr. Alan DeCherney, editor-in-chief of Fertility and Sterility and a UCLA professor of obstetrics and gynecology.

But other doctors said they would have expected some deaths and no investigation is warranted. They point to more than 4 million women who have safely used the patch and note that the FDA reports are called in voluntarily, rather than gathered scientifically.

The adverse events related to hormonal contraception are well documented and the patch does not appear to be responsible for significant events outside the expected profile except events like stroke & blood clots seem to occur with 3 times more frequency in patch users. This difference was observed in clinical trials and the trend appears to continue as observed in post-marketing safety surveillance via MedWatch reporting.

If you are a woman taking the pill who doesn’t smoke and is under 35, the chance that you are going to have a blood clot that doesn’t kill you is between 1 and 3 in 10,000. Your risk of dying from a blood clot while using the pill is about 1 in 200,000.

By contrast, with the patch, the rate of nonfatal blood clots was about 12 out of 10,000 users during the clinical trials, while the rate of deaths appears to be 3 out of 200,000.

J & J/Ortho McNeil stand behind Ortho Evra, but after hearing this little tidbit information last week (and what I know about the clinical judgment of a former director of mine that worked for Ortho before I worked for him), I'm a bit skeptical.

Risk factors for blood clots

Tags:clinical research; drug development; ethics; fraud; pharmaceuticals; Health; medicine; contraception

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