More adverse events tied to Pradaxa, warfarin than any other drugs in 2011, new report finds
If the number of adverse event reports the U.S. Food and Drug Administration receives is any indication, the blood thinner drug Pradaxa (dabigatran) could be one of the riskiest drugs on the market today.
An analysis of FDA records conducted by the Institute for Safe Medicine Practices, QuarterWatch, found that Boehringer Ingelheim’s Pradaxa topped the list of direct reports of adverse events the FDA received in 2011. According to the analysis, the FDA received 817 direct reports of adverse events blamed on Pradaxa last year. Adding the number of reports received by the manufacturer brought the total number of serious adverse event reports to 3,781.
The adverse event reports included 542 patient deaths, 2,367 hemorrhaging cases, 291 reports of acute renal (kidney) failure, 644 cases of stroke, and 15 cases of possible renal failure.
The FDA approved Pradaxa in 2010 for use in stroke prevention and to reduce the risk of systemic embolism in non-valvular atrial fibrillation (AF), a condition in which an irregular heartbeat enhances the risk of blood clots and strokes in patients. Almost all Pradaxa patients are elderly.
Pradaxa was hailed as a much-anticipated alternative to warfarin (Coumadin), a blood-thinning drug that has been used for decades but is notoriously difficult to maintain at proper levels within the patient. Past analyses have found that warfarin consistently ranks near the top of the list for adverse events directly reported to the FDA.
The FDA received 490 adverse event reports concerning warfarin in 2011 and an additional 616 reported to its manufacturer, Bristol-Meyers Squibb, the same year. Those reports, 1,106 in all, included 72 deaths.
Authors of the QuarterWatch report noted that the ranking of these two blood-thinning drugs at the top of the list for all adverse events reported to the FDA demonstrates how a “vulnerable patient population and powerful pharmacological action” have amounted to one of the “highest risks in prescription drug therapy.”
“While a therapeutic goal of preventing strokes, pulmonary embolism, and other harm through unwanted blood clots is a worthy objective, these results demonstrate that treatment is accompanied by substantial risks,” the report concluded.