Pradaxa is the number one reported drug to the FDA
Pradaxa ranks first among drugs most often reported to the FDA
  • Thu, 06/07/2012 - 10:27am

The Institute for Safe Medication Practices listed Pradaxa (dabigatran) as the drug most commonly reported to the U.S. Food and Drug Administration in 2011.

According to the report, the FDA learned of 179,855 adverse drug events last year. Of these, 88 percent were reported by drug manufacturers and 12 percent were reported by health care professionals and patients. 

Pradaxa, which has been on the market for two years, ranked first of five of the most commonly reported drugs to the FDA, followed by competing drug Coumadin (warfarin), which has been on the market since the 1950s. Both drugs were designed to combat blood clot-related risks associated with pulmonary embolism, stroke, and atrial fibrillation. But the report linked Pradaxa to 3,781 domestic serious adverse events, including 542 patient deaths, 2,367 hemorrhage cases, 291 acute renal failure cases, 644 strokes, and 15 suspected cases of liver failure.

Warfarin accounted for 1,106 reports, including 72 deaths. Warfarin and Pradaxa have often been compared and contrasted in their abilities to effectively combat dangerous blood clots. Warfarin is often viewed as the more “temperamental” drug, requiring  frequent blood tests. However, warfarin’s adverse reactions can be reversed with Vitamin K, whereas Pradaxa’s cannot.

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