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Ortho Evra’s Birth-Control Patch May Be Harmful

Originally published November 14, 2005

The Food and Drug Administration warned users of the 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 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.

Although most pills and the patch are loaded with 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.

More 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 blood clots while using the patch.

Documents released to attorneys as a result of that litigation show Ortho McNeil has been analyzing the FDA's death and injury reports, creating its own charts that document a higher rate of blood clots and deaths in association with the patch than with the pill.

This BeyeNETWORK news item contains information from a recent press release by the company mentioned.