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Date posted: 5/13/2013

The anticoagulant medication Pradaxa has been used by millions of patients with atrial fibrillation to prevent stroke since it was introduced in 2010. However, experts continue to debate whether it causes higher risks for fatal internal bleeding.

Now, patients should be aware that the maker of the drug, Boehringer Ingelheim, has quietly added additional warnings to the prescribing information that may signal more risks but will protect the company from injury claims down the road.

Pradaxa, an alternative to warfarin or Coumadin for patients with atrial fibrillation, has become a blockbuster drug for Boehringer, selling well over $1 billion with use in more than 70 countries.

However, many have warned that it may be more dangerous in cases of internal bleeding since there is no reversal agent.

Although the FDA has advised that Pradaxa is no more dangerous than warfarin, the Institute for Safe Medication Practices listed it as one of the most dangerous meds, and warned that those suffering Pradaxa bleeding are almost 5 times as likely to die than those with bleeding from Coumadin or warfarin.

Also, researchers from the University of Illinois at Chicago have suggested the data used by the FDA may be flawed, and the risk for Pradaxa bleeding may be higher than previously thought.

With all the negative attention, more doctors have questioned whether they should prescribe Pradaxa and hundreds of patients affected by internal bleeding have filed a Pradaxa lawsuit.

This led to increased warnings by Boehringer Ingelheim. First, they added a warning saying there was no reversal agent that could help stop internal bleeding.

Now, they updated the label last month to warn that patients using Pradaxa since its launch have reported thrombocytopenia, a condition causing a drop in blood platelets that can result in internal bleeding.

Already, more than 260 patients have filed a Pradaxa lawsuit alleging internal bleeding. With so many coming forward, cases are being consolidated into a special federal court in Illinois.

Those who require a blood thinner are strongly encouraged to ask their doctor about the safest option. If you or a loved one suffered internal bleeding after taking Pradaxa, it is important to speak with a lawyer about your legal options.

Due to the specialized nature of federal drug cases, DrugRisk only recommends lawyers who have already handled Pradaxa lawsuits.

Contact us today for more information on the research, side effects and litigation news related to Pradaxa and other drugs, or to speak with a lawyer.