Government watchdog groups are suggesting that the FDA approved the controversial anticoagulant Pradaxa despite knowing that the medication could cause users to experience uncontrollable bleeding risks.

The FDA approved Pradaxa for the consumer market in 2010. Since its release, thousands of patients have suffered from severe side effects of the anticoagulant medication. Some of those patients have taken legal action, joining hundreds of other injured parties who have filed Pradaxa lawsuits against the drug’s manufacturer, Boehringer Ingelheim.

Lawsuits against the company allege that the pharmaceutical manufacturer failed to warn consumers and the general public about the dangerous risks of using Pradaxa.

On October 15th, a report was released by the Project On Government Oversight (POGO) suggesting that the federal Food and Drug Administration was too permissive in approving Pradaxa. The POGO report suggests the FDA eased the drug’s passage onto the market. Potential issues with the FDA’s approval include the standards required for the drug’s clinical trials and what warnings would be required on the medication’s packaging.

According to the POGO report, researchers discovered that two years after its release, Pradaxa had become the most named medication in the FDA’s adverse event reports. Researchers suggest that by 2012 Pradaxa was the leading suspect in approximately 2,000 deaths.

When released, Pradaxa was aggressively advertised as the superior alternative to more traditional anticoagulants such as Warfarin or Coumadin, because Pradaxa does not require patients to follow dietary restrictions or undergo constant blood monitoring.

Unfortunately for many patients, until very recently no FDA approved antidote existed to reverse the blood thinning effects of the medication. Praxbind is the newly released Pradaxa antidote, but for many Pradaxa users this antidote has come too late.

The POGO report further criticizes the FDA’s support for Pradaxa, noting that the federal administration approved Pradaxa without a reversal agent, knowing that some patients would likely bleed to death without one. POGO also suggests that the clinical trials approved by the FDA were not blind and the doctors knew which patients were taking the actual medication.

According to the reports, because of this knowledge, the doctors often removed patients from taking Pradaxa at initial signs of trouble before adverse events such as strokes or uncontrolled bleeding could occur and be recorded.

Past lawsuits and investigators have also questioned the actions of the research institute involved in the clinical studies. Independent medical experts suggest the accuracy and veracity of the trials should be further investigated. The institute’s original reports have now been twice amended after admitting in 2010 that reports of as many as 81 complications associated with bleeding events, clots, heart attack and stroke were absent from the original reports.

Product liability attorneys continue to be available for potential plaintiffs looking to bring Pradaxa lawsuits. Successful Pradaxa lawsuits can help victims pay for both past and future medical bills as well as compensate victims for the pain and suffering they were forced to endure due to taking the medication.