EMA Issues Warning on Pradaxa Bleeding Risks

Share Article

The Pradaxa Resource Center is the Web’s largest source for information on Pradaxa research, side effects and legal news. Visit http://www.Pradaxa-lawsuits.org

Pradaxa lawsuit
The latest warning comes from Europe as lawsuits over patient death are already being filed in the United States.

The Pradaxa Resource Center, a patient advocacy group, is alerting patients who have taken or may be prescribed the drug Pradaxa of several warnings about internal bleeding risks. The latest warning comes from Europe as lawsuits over patient death are already being filed in the United States.

Pradaxa is a popular anticoagulant prescribed to patients suffering from atrial fibrillation in order to prevent strokes. According to an April 24, 2012 article in The Wall Street Journal, it is now considered a blockbuster drug after reaching the $1 billion sales mark for the 12-month period ending in February.

The FDA warned on December 7, 2011 that it was investigating the safety of Pradaxa after receiving higher than expected reports of injury or death. The manufacturer itself had just admitted to receiving more than 260 death reports from the drug.

In January, the Institute for Safe Medication Practices reported the FDA received more cases of Pradaxa internal bleeding during the first quarter of 2011 than with any other drug. This included over 500 cases of bleeding compared to only 176 from patients taking warfarin. Some of the side effects of Pradaxa included internal bleeding, heart attack, DVT, gastrointestinal problems and even death.

Most recently, the European Medicines Agency issued a statement on May 25th saying that, while they believed the drug still had positive benefits, warnings should be added to give doctors and patients a clearer picture of the risks.

Although all anticoagulants carry a risk of internal bleeding, most have a reversal agent available to doctors in emergency. A March 6, 2012 report by the Journal of Neurosurgery detailed a specific case and complaints by doctors that once Pradaxa causes internal bleeding in a patient, there is very little they can do to stop it.

Many patients affected by internal bleeding after taking the drug have now contacted the Pradaxa Resource Center to inquire about their legal options based on the failure of Boehringer Ingelheim to warn of the risks.

Those affected by the drug have already started filing Pradaxa lawsuits, such as the one filed last month by the family of a Tennessee woman who allegedly bled to death after taking the drug. The case is Marlene Wright et al v. Boehringer Ingelheim Pharmaceuticals, Case Number: 2:2012cv02262 (Western District Court of Tennessee)

Legal experts with the Pradaxa Resource Center urge anyone who has been affected by internal bleeding after taking the drug to speak with a lawyer about their legal options.

For more information on the research, warnings, side effects and legal options relating to the drug Pradaxa, or to speak with a lawyer, visit http://www.Pradaxa-lawsuits.org.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Chris Schroeder
Visit website