Lawsuit Alleges Causes Severe Menstrual Periods
The makers of face a new lawsuit alleging the blood thinning drug causes severe menstrual periods.
New York resident Kathy S. alleges in her lawsuit that she began taking as prescribed from Nov. 18, 2015 until Dec. 20, 2015. On Dec. 21, 2015 the plaintiff claims she required blood transfusions for severe menorrhagia with acute blood loss anemia as a direct result of taking .
“Plaintiff suffered various injuries, serious physical pain and suffering, medical, hospital and surgical expenses and loss of consortium as a direct result of use of ,” alleges the lawsuit.
According to the lawsuit, has been associated with severe bleeding events, which could include severe menstrual periods. Only a year after the drug was approved by the Food and Drug Administration in 2011, there were more than 1,000 reports of -associated serious adverse events, alleges the plaintiff. That year, the reports included 65 deaths, says the lawsuit, and the number only kept growing. By the end of the fiscal year, there were more than 2,000 adverse events reported to the FDA.
is often prescribed “for use as an oral anticoagulant, the primary purposes of which are to reduce the risk of stroke and systemic embolism in patients” after hip or knee replacement surgery, alleges the lawsuit.
The drug was marketed as more convenient than the safe alternative, warfarin; however, drug makers failed to warn doctors and patients about the risk of severe bleeding events, including severe menstrual periods, associated with the drug, says the plaintiff.
Compounding the problem, drug makers touted the single daily dosing and lack of blood monitoring. As opposed to warfarin, which requires patients to take blood tests and limit their diet, was marketed as easier. But, alleges the lawsuit, drug makers relied on flawed studies to make their marketing claims, putting patients at risk with the supposed “ difference.”
According to the lawsuit, the drug maker’s own studies showed that it was actually better for patients to undergo blood monitoring while taking . The plaintiff says that the drug makers ignored and even “systematically discarded” research results that went against their marketing scheme to further tout the drug which led to her severe menstrual periods.
“The use of without appropriate blood monitoring, dose adjustment and twice a day dosing can cause major, life-threatening bleeding events,” alleges the lawsuit. “Physicians using have to be able to balance the dose so that the blood is thinned enough to reduce the risk of stroke, but not thinned so much as to increase the risk for a major bleeding event. The Defendants were aware of this risk and the need for blood monitoring but have failed to disclose this vital health information to patients, doctors and the FDA.”
If you or a loved one experienced severe menstrual periods after taking , contact the experienced attorneys at McDonald Worley.
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