FDA’s New Warning on Contraception Patch Raises Questions
WASHINGTON, Nov. 15 -Women who use the Ortho Evra contraception patch are exposed to higher levels of estrogen that could be linked to problems such as blood clotting, according to the Food and Drug Administration’s new labeling requirement.
But Massachusetts doctors said that they would need more information before discouraging patients from using the once-a-week prescription patch.
Studies conducted by regulators and the patch manufacturer, Ortho-McNeil Pharmaceuticals (a Johnson & Johnson subsidiary) found that women who use the patch are exposed to 60 percent more estrogen over the course of a month than women who use typical birth control pills. Those findings prompted the new label warning, which informs users of the increased exposure.
Increased estrogen levels have been found to increase the risk of blood clotting; the FDA, however, said it was not known whether women using Ortho Evra were at higher risk than those taking the pill.
As the first federally approved skin patch for birth control, Ortho Evra has been used by an estimated four million women since it hit the market in 2002, according to the Ortho Evra Web site.
Hailed for its convenience, Ortho Evra is a thin, beige plastic patch that sticks to skin and is applied once a week in three-week intervals, releasing hormones into the bloodstream to protect against pregnancy.
Patch users receive higher levels of hormones, said Dr. Karen Loeb Lyfford, the medical director of Planned Parenthood League of Massachusetts in Boston, because of the contraceptive’s continuous delivery system.
Pill users experience daily peaks in hormone levels while Ortho Evra users receive a constant stream, Lyfford said. So in the course of a day the peak hormone levels of the pill are 25 percent higher than that of the patch. Over a month however, steady accumulation of estrogen from the patch results in higher overall levels.
More information is needed to determine if higher levels of estrogen cause problems such as blood clots in Ortho Evra users, she said.
“There is no medical reason that would make me not recommend it to patients,” Lyfford said. “But some patients may decide not to use it.”
The Associated Press, citing federal death and injury reports, said that about a dozen women in their late teens and early 20s died from blood clots believed to be associated with Ortho Evra use last year. Dozens more were afflicted with strokes and other clot-related problems, the AP reported.
“I would say these are anecdotal cases,” said Thomas Davidson, a physician with Andover Obstetrics and Gynecology, a group of area clinics , adding that more research is needed into why these deaths occurred.
Women who take the pill are also at risk for clotting, but pregnant women have an even higher risk rate of developing clots than both pill and patch users, Davidson said.
Despite this, some patients are worried.
“It is important to give them good information. A lot of people are asking about the reports,” Davidson said.
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