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More Ortho Evra® News
Many physicians have stopped prescribing the Ortho Evra® birth control patch, after the Food and Drug Administration (FDA) warned of increased hormone exposure to women who use it.
Ortho Evra® has revolutionized the birth control market. The thin waterproof patch is about the size of a matchbook and can be worn discreetly on the body while only having to change it once a week, eliminating the need to remember a pill everyday. But the FDA recently issued an announcement, requiring a new boldface warning on Ortho Evra's label stating that women who use the patch are exposed to 60% more estrogen then if they were taking a typical birth control pill. The increase in hormone exposure is due to the fact that hormones from skin patches get into the bloodstream and are metabolized differently.
Generally, increased exposure to estrogen may increase the risk for blood clots. The FDA has not made a statement about whether Ortho Evra® patch users are at greater risk for that.
Ortho Evra® has made a number of doctors and healthcare providers say they do not want to take any chances given the health risks. Henry Sullivant an obstetrician and gynecologist, says he stopped writing new patch prescriptions and suggests his patients who already use the patch to try other forms of contraceptives such as the pill or vaginal ring. Penn State University, who provides health services for over 42,000 students, stated it is no longer issuing Ortho Evra® prescriptions.
Because Ortho Evra® is especially popular among young women, many other university health officials are exercising caution. At the University of Texas, doctors are limiting refills to 3 months' worth and providing valuable information about the FDA's announcement. At both Stanford University and the University of California, Berkley, female students are being discouraged from trying the patch.
The recent FDA warning followed a European study of 32 women that measured hormone levels among subjects who took the pill versus those who took the birth control patch. It showed that women who use Ortho Evra® are exposed to 60% more total estrogen in their blood compared to the pill.
The pharmaceutical maker Ortho McNeil has 2 large scale studies under way that more extensively measure hormone levels and risks of Ortho Evra®.
Reference:
"Doctors back Off Birth-Control Patch After FDA Warning on Excessive Hormones, Some Stop Prescribing Popular Method; Weighing Choices," The Wall Street Journal, Anne Marie Chaker, November 2005.
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