LYCOS RETRIEVER 
Patch: Ortho Evra
built 651 days ago
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.
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A consumer fraud class action lawsuit is currently being investigated against Ortho-McNeil Pharmaceutical, Inc., makers of the Ortho Evra birth control patch. This investigation concerns whether Ortho-McNeil failed to disclose that the side effects and risks of blood clots, stroke or heart attacks are greater for women using the patch than for women using birth control pills.
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According to the FDA, two recent studies comparing the patch to similar oral contraceptives provide conflicting results. The studies do not address fatal blood clots associated with Ortho Evra, since the data the studies rely on is from claims paid by managed care plans.
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"This is a major medical problem affecting women everywhere," says John David Hart of the Law Offices of John David Hart in Fort Worth, who represents many women who have used the Ortho Evra patch. "The patch doesn't discriminate; it can endanger your life no matter your income, your ethnic background or your level of education."
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A group of doctors in Tennessee has decided to stop prescribing the Ortho Evra patch to patients over concerns that the device could increase their risk of blood clots or other problems. In a letter to their patients, the doctors cited a study which showed that women who use the Ortho Evra patch are at an increased risk of deep vein thrombosis, a type of blood clot in the leg which can lead to a heart attack or stroke.
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Internal documents show that Johnson and Johnson was well aware of the many health problems and complaints associated with the patch. In 2003, the company refused to fund further studies since the results might not be what they wanted and could hurt Ortho Evra sales.[11] It wasn't until late 2005, when the FDA announced an update on the labeling for Otho Evra, that Ortho-McNeil acknowledged these serious health problems associated with the patch.[11]
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