Pradaxa and Warfarin: FDA Evaluation Leads to Questions

According to federal drug regulators, Pradaxa and warfarin present comparable risks of internal bleeding.  However, some experts feel that the methodology behind this statement is flawed because it does not take into account the fact that, unlike warfarin, there is no reversal agent for Pradaxa internal bleeding.

In October 2010, Boehringer Ingelheim introduced Pradaxa (dabigitran) as an alternative blood thinner to warfarin, used to prevent strokes and heart attacks in patients with atrial fibrillation.  Pradaxa was touted as superior to warfarin (Coumadin), which requires accurate dosing and strict dietary restrictions.  Within the first two years Pradaxa was on the market, more than 750,000 prescriptions for the anticoagulant were issued in the United States.  Unfortunately, doctors soon discovered that while both drugs present a risk of severe internal bleeding, warfarin bleeds can be reversed with a dose of Vitamin K and there is no such reversal agent for Pradaxa hemorrhages.

An unacceptably high number of adverse event reports during the first year Pradaxa was on the market caused great concern in the medical community and prompted the FDA to announce a formal evaluation of Pradaxa bleeding risks in December 2011.  On November 2 of this year, the FDA issued a drug safety communication to update doctors and the public of the status of this ongoing review, stating that research has shown a comparable bleeding risk between Pradaxa and warfarin.

The FDA findings were based on information from insurance claims and data from an ongoing safety pilot program called Mini-Sentinel.  During the evaluation, actual rates of gastrointestinal bleeding and brain hemorrhages were compared amongst new users of Pradaxa and new users of warfarin.  The researchers concluded that rates of Pradaxa bleeding do not appear higher than warfaring bleeding rates.  These findings are consistent with statistics reached in a similar Boehringer Ingelheim clinical trial.

In response to the FDA’s statement, Boehringer Ingelheim issued a press release reaffirming Pradaxa’s safety.  Opponents of the drug say that the trouble is not in preventing Pradaxa bleeds that is important, but the inability to stop these bleeds that really needs to be taken into account.  Because Pradaxa bleeding events can’t be stopped, they are more dangerous than warfarin bleeding events which can be reversed.

The Observational Medical Outcomes Project (OMOP) is a non-profit group dedicated to proper analysis of drug data.  Though the group includes experts from the FDA, they have called into question the accuracy of the FDA’s evaluation.  Earlier in 2012, the Institute for Safe Medication Practices (ISMP) conducted an analysis of all adverse event reports concerning either drug submitted to the FDA during 2011.  The found 2,367 reports of Pradaxa bleeding incidents, and 542 reports of these incidents leading to the death of a patient.  In contrast, only 1,106 adverse event reports were associated with warfarin, and 72  deaths.

Pradaxa Lawsuit Information

A growing number of people who have suffered injury or the death of a loved one linked to Pradaxa side effects have filed dangerous drug lawsuits against Boehringer Ingelheim.  The federal court system has received roughly 120 complaints, which have been consolidated as part of a multidistrict litigation (MDL).

All of the Pradaxa lawsuits are based on similar claims that Boehringer Ingelheim did not conduct adequate research before releasing Pradaxa, and that they aggressively marketed the drug based on its proposed safety over warfarin.  Plaintiffs also allege that the drug maker did not sufficiently warn of the dangers associated with Pradaxa.  If you or someone you care about has suffered as a result of Pradaxa internal bleeding, you could be entitled to substantial compensation.  Contact a pharmaceutical product liability lawyer to schedule a free legal consultation.



Nov. 26, 2012 | Tags: Dangerous Drugs, Pradaxa

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