Transcript - Pradaxa - May Lead to Serious Bleeding Events and Death

40% of all deaths and serious bleeding events related to the popular blood-thinning medication Pradaxa could have been avoided by simple blood testing. Pradaxa is a best selling prescription medication intended to reduce the risks of stroke in patients with atrial fibrillation, or a-fib, a heart rhythm disorder.

Prior to approving the drug, researchers found that monitoring the blood levels of patients periodically could allow doctors to lower the dose of the drug or stop it temporarily in patients who have dangerously high levels of Pradaxa in their blood. The ability to prescribe Pradaxa without requiring regular blood tests is one of the chief selling points of the drug, which generated $837 million in U.S. sales in 2013.

This is not the first time Pradaxa has been in the spotlight. In 2011, just one year after the drug was introduced to the market, Pradaxa was one of the most frequently mentioned drugs in the FDA’s database of adverse events. Fatalities from using the drug climbed to over 500.

In May 2014, Boehringer Ingelheim, the makers of Pradaxa, settled more than 4,000 lawsuits for $650 million. Claims spanned from 2010 to beyond 2013 after users experienced side effects such as hemorrhaging. Even after the settlements, Boehringer Ingelheim stands by Pradaxa and maintains the drug is safe. Researchers would like to eliminate the recommendation that patients do not need routine anticoagulant monitoring. They also contend that the FDA should approve a lower dose than is currently available, which could reduce serious bleeding without loss of efficacy in preventing strokes.

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