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Ortho Evra patch linked to blood clots and strokes
The Ortho Evra birth control patch has been linked to 21 life-threatening blood clots and other ailments according to reports received by the Federal Drug Administration. The contraceptive patch, manufactured by Ortho-McNeil, has been marketed to consumers and doctors as a convenient alternative to oral birth control pills. Approximately 4 million women have used the Ortho Evra Patch since it was approved in 2001.
A survey by the Associated Press of reports of patch related problems to the FDA raises the possibility that the threat of clotting with the patch is greater than with the pill.
According to the AP survey, the risk of death with the patch could be about three times greater than with the pill. The news agency found that there were 12 clot-related deaths among the approximately 800,000 users of the patch in 2004.
FDA Warns Clot Risk Higher in Birth Control Patch than Pill
January 18, 2008 - Based on the results of a new study that discovered the increased danger, the U.S. Food and Drug Administration said it has approved changes to the labeling for the Ortho Evra Contraceptive Transdermal Patch, to better warn women and their doctors of the potential risk.
"For women that choose to use contraceptives, it is important that they thoroughly discuss with their health-care providers the risks and benefits involved," Dr. Janet Woodcock, deputy commissioner for scientific and medical programs at the FDA, said in a statement.
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