The Food and Drug Administration yesterday issued a warning to women who use the Ortho Evra birth control patch, saying it allows higher levels estrogen into the bloodstream than pills do, increasing the risk for blood clots.
Manufacturers and regulators have long claimed that birth control patches contained the same levels of estrogen as birth control pills, producing no greater risk for clotting or death. But it makes a big difference when that estrogen gets absorbed through the skin directly into the bloodstream, as it does with the patch. When women take a pill, estrogen enters the bloodstream through the digestive tract, and about half the dose is lost in the process. Pills also cause spikes in estrogen levels that last only a few hours, while the patch delivers the hormone steadily throughout the day.
Yesterday Ortho McNeil added warnings its patch labels, telling women that if they use the product, they will be exposed to 60 percent more estrogen than they would if they used regular pills.
It's about damn time.
People have been asking questions about the safety of the birth control patch almost since its introduction in 2002.
Four months ago, an Associated Press investigation revealed that patch users suffer a three times higher rate of clotting and death than women on the pill. The AP also reported on a dozen women in their teens and early 20s who died from blood clots "believed to be related to the birth control patch, and dozens more survived strokes and other clot-related problems."
In September, Public Citizen Health Research Group added Ortho Evra to its list of dangerous medications, while last month, the AP reports, OB-GYN Miguel Cano of Reedley, Calif., wrote to "several thousand" women patients recommending that they discontinue use of the patch.
A spokeswoman for Ortho McNeil told the AP that the warning speaks for itself and that her company is cooperating with the FDA.
But the AP also reports that documents released to attorneys show that Ortho McNeil has long been analyzing the death and injury reports among patch users, and that an internal Ortho McNeil memo shows that in 2003, the company declined to fund a study comparing the patch to the Ortho-Cyclen pill because there was "too high a chance that study may not produce a positive result for Evra."
Maybe this is the kind of thing that will get the birth control industry off its butt to start developing new nonhormonal forms of contraception.
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