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    Friday, November 11, 2005

    Litigating Hormones: The latest drug to come under litigation fire is the birth control patch, Ortho-Evra, which has prompted the FDA to issue a warning:

    The Food and Drug Administration on Thursday warned millions of women who use the Ortho Evra contraceptive patch that they are being exposed to about 60 percent more estrogen than with a typical birth control pill, which could put them at higher risk for blood clots.

    The labels on the medication will be updated with the warning, the FDA said. Most daily birth control pills contain 35 micrograms of estrogen.

    In July, 10 women filed a lawsuit against the two companies, claiming the patch caused them to suffer strokes and blood clots. The lawsuit -- filed in Hudson County, N.J., Superior Court -- alleges that the patch is "defectively designed" and "unreasonably dangerous."


    According to the FDA, the amount of estrogen delivered by the patch is more than the 35 microgram pill, but less than the 50 microgram pill. Interestingly, although the day-to-day exposure to estrogen is higher with the patch, the 35 microgram pills have higher peak levels:

    The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximum amount of estrogen to which women are exposed is about 25% lower with Ortho Evra than they are with typical birth control pills.

    In other words, you get a brief surge of estrogen with the pills that you don't get with the patch.

    Either way, any type of estrogen will raise the risk of blood clots and strokes. This is common knowledge, and it's a potential side effect that doctors review with their patients before beginning hormonal contraceptives, and one that is included in the pamphlets that pharmacies dispense with their drugs. Which leaves one wondering, what are those women and their lawyers thinking? Did they think because they absorbed the estrogen from their skin instead of their GI tracts that it took away all the risks?
     

    posted by sydney on 11/11/2005 06:01:00 PM 0 comments

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