More than 250 suffered side effects, such as gastrointestinal, rectal, and brain bleeding, by using the blood thinner Pradaxa, and have now filed lawsuits against Boehringer Ingelheim Pharmaceuticals, the drug’s manufacturer. Doctors wrote millions of prescriptions for the drug because Pradaxa was heavily marketed as safe and effective after the FDA approved the drug in October 2010.
In the first year, more than 540 patients died as a result of using Pradaxa and thousands of others have reported suffering from serious side effects.
Those who have been injured by Pradaxa are claiming that Boehringer ingelheim:
Failed to warn and/or disclose information regarding the risks of serious and excessive side effects such as uncontrollable and sometimes fatal bleeding.
Did not institute treatment or protocol methods for those who experience severe bleeding as a result of using the drug.
Failed to adequately research the safety of the drug and establishing the variables in recommending dosing of Pradaxa.
Intentionally concealed the fact that Pradaxa is a dangerous drug.
Failed to warn consumers.
Marketed Pradaxa as a more convenient and safer drug that warfarin, the standard blood thinning medication. The reality was, studies showed Pradaxa had the same or higher risk for bleeding than warfarin. However, warfarin has an antidote to be taken by those who experience excessive bleeding, whereas, Pradaxa does not.
Lawsuits claim that the manufacturer of Pradaxa did not adequately label the drug. Labels and prescribing information that was printed between October 2010 and March 2011 did not:
Include proper dosing information in respect to patient’s weight.
Warn about gastrointestinal bleeding was not provided, specifically for patients with GI issues.
Warn about the risk of bleeding in older patients or other at-risk patients.
Warn that there was no antidote or established method to treat patients who suffered from excessive bleeding.
Thousands of others have reported severe bleeding injuries because they used Pradaxa.