A new drug to treat those with atrial fibrillation has come under fire for being linked to a number of bleeding deaths in the United States. The anti-clotting drug Pradaxa, manufactured by German drug maker Boehringer Ingelheim, has been on the market for just two years, but complaints have arisen that it was not properly vetted by the FDA before being approved. A New Jersey injury attorney like those at Gersowitz, Libo & Korek P.C. can help you when you’ve been injured by Pradaxa.
Pradaxa has been linked to more than 500 deaths. It is used as a replacement for warfarin, the 60-year-old blood thinner used to prevent strokes in those with the heart disorder atrial fibrillation. Since its approval in October 2010, Pradaxa has become a blockbuster drug, raking in more than $1 billion in sales. The drug has also been prescribed to 17 percent of patients with atrial fibrillation, or about 725,000 patients in the United States according to the FDA, due to being seemingly more effective at preventing strokes.
Investigating Pradaxa
However, doctors and victims’ families have begun campaigning against the drug, warning that it was not sufficiently tested in trials, and it was identified as the main suspect in 542 deaths in 2011, according to the FDA. Patients who take warfarin need to be carefully monitored and given frequent blood tests to monitor the drug’s effects, while Pradaxa requires no such monitoring, and has no antidote yet.
In a study released in November, the FDA examined hospital data and health insurance claims and found that the rates of bleeding with Pradaxa were similar to those for warfarin, and it had a higher success rate.
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For more information about Pradaxa causing deaths from uncontrollable bleeding, or about medical malpractice, contact the New Jersey injury attorneys at Gersowitz, Libo & Korek, P.C. by calling (800) 529-9997.
