FDA's Pradaxa Study May Be Flawed & Misleading

Year Long FDA Pradaxa Study May Be Deeply Flawed

Over 500 people have died from the popular blood thinner drug, Pradaxa.  As reported deaths rose, the U.S. Food and Drug Administration (FDA) began a year long investigation into the drug and its effects upon the human body.  As a result, the FDA released its conclusions last week, stating Pradaxa was no more dangerous than other blood thinner medications like Warfarin.  But new evidence suggests that this study may have reached premature conclusions and may have been deeply flawed.

In September, the Journal for the American Medical Association (AMA) declared the release of Pradaxa may have been too premature.  Studying the initial trials, the AMA expressed concern for the many internal bleeding events that went overlooked when this drug was approved by the FDA.  Similarly, USA Today reported in August that the FDA had received 3,781 complaints of adverse health effects and over 542 deaths attributed to Pradaxa.  For the FDA to ignore these complaints and classify the drug as no more dangerous than its competition seems suspicious to some health experts.

Were the FDA's Conclusions Merely Guesses?

Critics state the FDA has failed to take the incidents of internal bleeds into account and the fact that Pradaxa has no reversal agent, unlike other blood thinner medications.  Doctors have been quick to point out that the FDA's methodology appears to be flawed.  The FDA has been using unadjusted incident rate ratios to determine Pradaxa's safety, which leading medical authorities have found severely lacking.

This alleged flawed methodology is important because in some instances, it compares drug outcome pairings where there is no causal relationship.  Medical researchers state that this amounts to little more than a guess or a shot in the dark.  Researchers further point out that the comparisons seem to be skewed towards drug outcome pairs with known causual relationships such as Warfarin.  In a very real sense, it seems Warfarin's reputation is skewing the results unfairly.

If You Have Been Injured By Pradaxa

Despite this FDA study, the Institute for Safe Medical Practices reports Pradaxa is among the drugs responsible for a 37% increase in prescription drug complaints.  Because of the high number of Pradaxa injury complaints, the litigation against Pradaxa drug maker Boehringer Ingelheim is expected to be complex and lengthy.  Federal Judge Herndon in the Southern District of Illinois has issued an order on July 24, 2012 authorizing patients injured by Pradaxa to proceed with multi-district litigation in case number MDL No. 2385, IN RE: Pradaxa Product Liability Litigation. 

If you have been injured by Pradaxa, please call an experienced product liability attorney.  Your blood thinner injury could be severe enough to affect your entire life and your quality of life.  In order to protect your rights and gain the compensation you need, you should speak with a skilled product liability attorney today.