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.
Until 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 birth control 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.
"I wish I had known. It's quite likely I would never have used it," said Jennifer Cowperthwaite, 26, of Broad Brook, Conn., who still suffers breathing problems after a blood clot reached her lungs two years ago after she used the patch.
"Many women find the patch a more convenient method of birth control," observes The Early Show medical correspondent Dr. Emily Senay.
She points out that the patch went on sale in 2002 with a high profile ad campaign featuring sexy models.
Although most birth control pills and the patch have 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.
Thursday'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.
Citing 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.
Ortho McNeil spokeswoman Bonnie Jacobs said the warning speaks for itself and that the company has been cooperating with the FDA, which distributed the new warning to health care providers.
The company recommends that women speak to their doctors about the risks and benefits of the patch, Senay notes.
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