Problems with Pradaxa Top FDA Adverse Event Reports in 2011

The blood thinner Pradaxa was linked to hundreds of deaths in the the United States last year, according to a new report on adverse events submitted to the FDA, and the total number of reports involving problems with Pradaxa far exceed other drugs that were monitored. 

The Institute for Safe Medication Practices (ISMP) released their Quarterly Watch report (PDF), which evaluates adverse event reports submitted by doctors and patients through the FDA MedWatch program during 2011.

Overall, the FDA received at least 3,781 reports involving serious injuries associated with the use of Pradaxa, including 542 patient deaths. The adverse event reports surpassed all other medications regularly monitored by the group in reports of hemorrhage (2,367), acute renal failure (291) and stroke (644).

Pradaxa (dabigitran) is a relatively new anticoagulant that was introduced by Boehringer Ingelheim in October 2010 as a superior alternative to Coumadin (warfarin) for prevention of stroke among patients with atrial fibrillation.

Warfarin, the generic name for Coumadin, which was introduced in 1954 and has been the mainstay of anticoagulation treatment for decades, was linked to 1,106 adverse event reports, including 72 deaths.

Although Pradaxa has been promoted as superior and easier to use than warfarin, because it requires less monitoring, Pradaxa does not have an easy reversal agent that can be used to quickly stop bleeding problems that may develop.  While doctors can give patients taking warfarin a dose of vitamin K if bleeding problems occur, no such antidote is available to address bleeding that may develop while on Pradaxa.

Boehringer Ingelheim faces a growing number of Pradaxa lawsuits brought on behalf of individuals who have experienced problems, alleging that the drug maker failed to adequately warn consumers and the medical community about the serious and potentially life-threatening bleeding risks, as well as the lack of a reversal agent.

A Pradaxa safety investigation into the reported bleeding problems and deaths is underway by the FDA, to determine what regulatory actions should be taken to protect consumers from the risk of problems with Pradaxa.