Birth control patch riskier than using pill, FDA says

WASHINGTON -- The Food and Drug Administration warned users of the popular Ortho Evra birth control patch that they are being exposed to more hormones, and are therefore at higher risk of blood clots and other serious side effects than previously disclosed.\nUntil now, regulators and patch-maker Ortho McNeil, a Johnson and Johnson subsidiary, had maintained the patch was expected to be associated with similar risks as the pill. But a strongly worded warning was added to the patch label Thursday that says women using the patch will be exposed to about 60 percent more estrogen than those using typical birth control pills.\nAlthough most pills and the patch contain the same amount of estrogen, hormones from patches go directly into the bloodstream while pills are swallowed and digested first. The result is that women using the patch have much higher levels of estrogen in their bodies.\nThursday's warning comes four months after The Associated Press reported that patch users die and suffer blood clots at a rate three times higher than women taking the pill.\nCiting federal death and injury reports, the AP also found that about a dozen women, most in their late teens and early 20s, died in 2004 from blood clots believed to be related to the birth-control patch, and dozens more survived strokes and other clot-related problems.\nOrtho McNeil spokeswoman Bonnie Jacobs said the warning speaks for itself and the company has been cooperating with the FDA, which distributed the new warning to health care providers. \nMore than 4 million women have used the patch since it went on sale in 2002. Several lawsuits have been filed by families of women who died or suffered from blood clots while using the patch, and lawyers said more are planned.\nHormone levels in women on the pill are highest one or two hours after taking it, Miller said. Twelve hours later, estrogen levels are quite low, meaning the body is not exposed to high levels of estrogen 24 hours a day.\nBut the patch causes higher estrogen levels because delivery of medication continues all day. Those elevated levels may be high enough to increase some women's risk of blood clots, Miller said.