In the midst of an FDA warning over the safety of Pradaxa, several lawsuits alleging patient death and growing public concern over uncontrollable internal bleeding, the maker of the drug has released a new study which unsurprisingly shows the drug is safer than alternatives.
On December 7, 2011, the FDA announced it would launch an investigation into the safety of Pradaxa after receiving hundreds of reports of patient death. Experts say nearly 1,000 people in all have suffered injury or death after taking the drug.
Pradaxa has been prescribed over 1 million times to over 300,000 patients suffering from atrial fibrillation in an effort to prevent blood clots. However, drug experts point to the risk of internal bleeding from the drug.
Although internal bleeding is a concern in all anticoagulants, other drugs like Coumadin and Warfarin have a reversal agent like vitamin K which doctors can use to fight the bleeding. There is no such reversal agent for Pradaxa.
The maker of Pradaxa, Boehringer Ingelheim, recently admitted to receiving more than 260 reports of patient death from the drug. However, they are fighting back at the bad press by funding a new study.
According to a new study published in the medical journal Stroke which was funded by Boehringer Ingelheim, researchers from McMaster University found that Pradaxa users had one-third fewer brain bleeding deaths and half as many serious brain bleeding events as users of Coumadin or Warfarin.
However, critics are quick to point out that the original RE-LY clinical trial of Pradaxa from which the latest study drew its figures may have had flawed data. Also, the study doesn’t account for the fact that Boehringer Ingelheim failed to warn users that the drug didn’t have a reversal agent.