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A new FDA warning alerts consumers about potential dangers of the Ortho Evra® patch. First approved by the FDA in November 2001, the Ortho Evra® birth control patch is a transdermal patch that is applied to the skin and worn for one week.

The patch is replaced every week for 3 weeks, followed by one patch-free week. Currently, Ortho Evra® is the only birth control patch available and its unique method of administration sets it apart from other contraceptive options on the market. The makers of the patch, Ortho-McNeil Pharmaceutical, Inc., have advertised it as a safe and convenient alternative to the popular birth control pill.

Since its approval, the patch has been prescribed to nearly 5 million women. Initially, the manufacturer informed consumers that the risk of serious complications from patch use was similar to the risks associated with oral birth control use. More recent research, however, shows that women who use the patch are actually exposed to 60 percent more estrogen the pill users, and in November 2005, a warning was added to the Ortho Evra® label to alert consumers about the dangers of increased estrogen exposure, which can include heart attacks, strokes, and blood clots. These serious health risks can result in coma or death.

Unfortunately, for some Ortho Evra® birth control patch users, the new warning is far too late. Well over 10,000 reports of adverse reactions and nearly 50 serious injuries and deaths have been linked to the product. As the startling risks of the patch become more evident, the number of life-threatening injuries and deaths that have been linked to its use continues to grow. Davis, Unrein, McCallister, Biggs and Head, L.L.P., can provide assistance to victims who have suffered serious injury as a result of the Ortho Evra® patch and to the families of victims who died as a result of patch use. We have the knowledge and record of success you are looking for. Please contact our attorneys today to discuss your case.

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