Drug safety concerns were raised last week over Boehringer Ingelheim’s highly touted blood-thinning drug Pradaxa after an internal research study was released that found the company had failed to properly warn patients about the risks of taking the drug. One of the drug’s main marketing points has been brought into question: that Pradaxa does not require regular blood tests to ensure it is working properly.
Thomas Moore, a senior scientist at the Institute for Safe Medication Practices commented, “The one-size-fits-all was a mistake for a drug with this kind of risk.” The Institute rated anticoagulants like Pradaxa as a serious safety problem that has been responsible for more than 1,000 deaths through 2012.
Approved in 2010, the drug, which can cause fatal bleeding, has annual U.S. sales of more than $2 billion. The newly released documents show that drug makers and regulators had been too eager to approve such powerful drugs without more careful evaluation.
Injured victims and their families can file a product liability claim against the manufacturer including medical expenses, hospital costs, permanent injuries, pain and suffering, and wrongful death.