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Complications with the Ortho Evra Patch
The popularity of Ortho McNeil''s Ortho Evra patch continues to grow, backed by millions of dollars in advertising. FDA approved the patch in November 2001, Ortho Evra entered the U.S. market in 2002 and has since been used by more than five million American women in less than three years. Despite the drug''s popularity, including being chosen as one of Time magazine''s “Coolest Inventions” in 2002, complications of the Ortho Evra patch have been reported, and an Associated Press report said there is a risk of death with the patch that could be about three times greater than with the pill.
The AP said about a dozen women, most in their late teens and early 20''s, died in 2004 alone from blood clots believed to be related to complications of the Ortho Evra patch. In addition, dozens more women survived strokes and other clot related problems. Blood clots are a known and serious risk of all hormonal contraception, but it is not a common risk, especially among women younger than 35.
The complications of the Ortho Evra patch, however, are hard to determine because the AP report was derived from FDA data with a database containing 16,000 different adverse events. Though complications of the Ortho Evra patch ranged from mild rashes to deaths, the FDA''s reporting system is voluntary and has other deficiencies that make it impossible to draw reliable conclusions from in order to determine the real risks of various reported complications of Ortho Evra.
Ortho McNeil refuted the AP report, saying the data quoted was based on voluntary reports that carry “a significant amount of uncertainty regarding the validity of the information,” according to Katherine LaGuardia, M.D., director of medical affairs at Ortho Women''s Health. Early warning signs, however, may have been present for years, indicating there could be serious and potentially fatal complications of the Ortho Evra patch that were not further investigated.
In 2000, doctors at the FDA reviewing clinical trial of the patch warned of the potential risk of blood clots prior to approval of the devices. In the trials, two of the 3,300 women using the patch were treated for blood clots that traveled to their lungs, but Ortho McNeil says one of those women should not be counted because she had undergone surgery. Still, the AP reported that an FDA medical reviewer recommended the agency conduct a study regarding the risk of blood clots associated with the use of the Ortho Evra patch at the time of the product''s approval in November 2001. The FDA never required the study.
Despite the questions about complications of the Ortho Evra patch that were presented before the device hit the market, there were no follow-up requirements for studies beyond the routine FDA reviews of reports called in by consumers, doctors and manufacturers. Ortho McNeil says the complications of the Ortho Evra patch are consistent with those carried by the pill, but the label''s safety warning says the patch is expected to be associated with similar risks as the pill, then later says it is unknown if the risk of blood clots from the patch is different from the pill.
The AP report focused on data from 2004, when the patch was more widely used. Anyone concerned about suffering possible complications with the Ortho Evra patch is encouraged to speak with a physician before deciding if another hormonal contraceptive will offer advantages. Women have the right to have access much information as to make a fully informed decision about the benefits and risks of their contraceptive choices, and if there are increased complications of Ortho Evra patch risks, it is both the FDA and Ortho McNeil''s responsibility to perform more studies to better evaluate risk factors.
Have you been injured by the Ortho Evra Patch?
If you or a loved one has developed a blood clot or any other serious birth control patch problem, please contact us to speak with an experienced attorney in your area.
Product Liability Breaking News
"Ortho Evra Lawsuits Continue to Roll in"
The number of Ortho Evra lawsuits continues to rise as more and more women argue they suffered blood clot injuries after using the birth control patch. To date,...
"J & J Wants to use Pre-emption for Immunity"
The maker of the Ortho Evra birth control patch is seeking legal protection from lawsuits over injuries caused by the product with argument...
"FDA Approves Label Change for Ortho Evra"
The Food and Drug Administration approved a labeling change for the Ortho Evra birth control patch based on a new study linking the contraceptive to a greater risk of potentially fatal blood clots than the pill.
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