Pradaxa is one of the new class of blood-thinning medications intended to reduce the risk of stroke and systemic embolism in patients with irregular heartbeats (Atrial Fibrillation or A-Fib).

Produced by German pharmaceutical company Boehringer Ingelheim, Pradaxa entered the market in October 2010, designed to replace the widely used warfarin (Coumadin).

While clinical results conducted by Pradaxa’s manufacturer looked promising, the results of those same clinical trials have been called into question according to reports that Boehringer Ingelheim did not reveal relevant information from those studies at the time that the blood thinner was brought to market.

Is it Safe?

By 2011, hundreds Pradaxa lawsuits were filed against Boehringer Ingelheim for damages suffered as a result of Pradaxa side effects, including gastrointestinal bleeding, as well as brain and rectal bleeding.

These Pradaxa lawsuits claimed that Pradaxa side effects put patients at a greater risk for life-threatening and fatal bleeding events because Boehringer Ingelheim overstated the efficacy of the anticoagulant, failed to adequately disclose to patients that there was a lack of a reversal agent to control bleeding in patients, and failed to disclose to patients that blood tests would be required to monitor dosage levels for the safest use of the drug.

Pradaxa lawsuits were later consolidated into a multidistrict litigation in the U.S. District Court for the Southern District of Illinois. Eventually, the litigation grew to nearly 4,000 individual cases. In May 2014, Boehringer Ingelheim agreed to pay $650 million to settle these cases.

In 2014, the British Medical Journal reported that through this litigation it was discovered that Boehringer Ingelheim had withheld internal analysis that would improve the safety of the drug. This internal analysis involved the company’s awareness of the need to monitor blood levels of Pradaxa users and adjust doses of the drug to allow a safer use of the product and reduce the number of bleeding events.

According to the BMJ article, the analysis was not shared with regulators because it likely would have affected sales.

All in all, there have been hundreds of deaths caused by the drug, and, according to the Journal of Neurosurgery, bleeding complications from Pradaxa are generally irremediable. Another study in January 2012 by Archives of Internal Medicine evidenced a link between the use of Pradaxa and a higher risk of heart attack — 27 percent to 33 percent higher — when compared to similar medicines.

Despite these concerns, Boehringer Ingelheim maintains that the blood thinner is safe for use without dose monitoring and that any information not released was either not relevant or not scientifically significant.

Pradaxa Lawsuit Information

Pradaxa lawsuits filed in state and federal courts across the United States allege the manufacturer was negligent in not issuing immediate warnings to healthcare professionals and consumers concerning the mounting risks of serious and potentially fatal bleeding events associated with taking Pradaxa.

If you have been injured or lost a loved one due to serious Pradaxa side effects, you may have grounds to file a Pradaxa lawsuit.  An experienced drug injury attorney can review your case at no charge and help you in deciding if filing a Pradaxa lawsuit is right for you.