Thomas J. Lamb Drug and Medical Device Litigation Law Blog on Lawyers.com

ISMP Quarterwatch 2010 4th Quarter: Hemorrhages And Thromboembolic Events Have Been Reported To FDA

(Posted by Tom Lamb at www.DrugInjuryWatch.com on October 13, 2011; see

http://bit.ly/r6kekn)

To start, according to the responsible drug company Boehringer Ingelheim Pharma:

PRADAXA is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem.

www.Pradaxa.com (accessed 10/13/2011)

The 2010 Quarter 4 Quarterwatch from the Institute for Safe Medication Practices (ISMP) shows that, despite only being on the US market for a year / since October 2010 , the FDA has received an unusually high number of "early" adverse event reports about Pradaxa (dabigatran) involving the drug's effects on blood clotting, namely hemorrhages (too much anti-clotting effect) and thromboembolic events (too little clot inhibiting effect) such as pulmonary embolism (PE) and deep vein thrombosis (DVT).

These ISMP Quarterwatch findings are summarized in an October 2011 article, "Latest review of FDA safety reports shows wide use of Pradaxa", written by Michael Cohen, who is President of the ISMP group:

... [O]ne of the interesting findings in this issue of QuarterWatch involves the new drug Pradaxa (dabigatran etexilate). Within weeks of its launch, Pradaxa generated more reports (307) than 98.7% of the other drugs we regularly monitor. The predominant reported adverse effects were equally divided among bleeding or clotting events....

This large number of reports in the 2-3 months after launch illustrates that serious safety issues are likely to grow as the use of Pradaxa increases and forthcoming new alternatives to Coumadin are approved. The large number of reports just weeks after approval show how quickly a new treatment can spread into wide clinical use.

To compound the scope of this possible emerging drug safety issue involving Pradaxa, the Cohen October 2011 news article about the ISMP Quarterwatch findings concerning Pradaxa went on to tell us how this relatively new atrial fibrillation heart drug is already being prescribed to a much wider patient population than the actual "indication", i.e., reducing the risk of blood clots and stroke in patients with a heart condition known as atrial fibrillation, for which it has received FDA approval:

We also found that this new drug was immediately used “off-label,” meaning that the FDA has not approved the drug for use in the manner in which it’s being prescribed because its risks and benefits have not yet been systematically studied. Only 36% of reports that listed the indication noted that the drug was being used for the approved indication. Another 46% of reports said the drug was being used to prevent blood clots or stroke in general terms, and other reports clearly specified off-label uses, such as the prevention of deep vein thrombosis postoperatively after hip or knee arthroplasty. The data suggest that physicians were substituting Pradaxa for warfarin across a wide spectrum of conditions, despite not having FDA approval.

Of course, we will continue to monitor the safety profile of Pradaxa and, as always, we welcome any Comments that you may have regarding this relatively new drug from Boehringer Ingelheim Pharma.