Patch poses risks for women
November 17, 2005
Ortho Evra, the popular birth control patch, is receiving new warning labels cautioning women that it releases 60 percent more estrogen into the bloodstream than the average pill.
Higher levels of estrogen in a woman’s bloodstream create a higher risk for blood clots.
The Food and Drug Administration approved the new labels Nov. 10. The government organization maintains previous warnings stating that it is not known whether there is a direct connection between women using Ortho Evra and a heightened risk of developing a blood clot.
The FDA and Ortho-McNeil, the company that makes the birth control patch, are both continuing to study the possibility.
Until more information is available, the University Health Center is not advising patients to use the patch.
“We are not particularly recommending it at this point if someone asks us what we think or what options they have,” said nursing manager Lori Christopher. “We kind of want to see what plays out with the FDA.”
Freshman exploratory major Patricia Dionne’s outlook on using Ortho Evra is not affected by the FDA’s new warning labels.
“I’ll stay on it,” Dionne said. She has been using the patch for a year and a half.
The additional warning came after the FDA and Ortho-McNeil compared the levels of estrogen in the patch versus the pill. Most prescribed birth control pill doses are 35 micrograms, according to the FDA. Not all estrogen in the pill enters the bloodstream because it must be digested and absorbed through the intestines.
Ortho Evra is a thin plastic square that women apply to their skin once a week for three weeks monthly. Hormones are released directly into the bloodstream.
“There is an increased steady amount of estrogen,” Christopher said.
The label revisions come after The Associated Press released results of a study this summer. The study showed that women who use Ortho Evra have a risk of dying from a blood clot three times higher than women on the pill.
The AP found for non-smoking women under the age of 35, three in every 200,000 women on the patch died of strokes or blood-clots related problems, versus one in every 200,000 women on the pill.
According to the same information, 800,000 women used the patch in 2004. Of these women, a total of 12 died and dozens more experienced strokes and other blood clot-related problems.
Contact general assignment reporter Leslie Schelat at [email protected].