The Institute for Safe Medical Practices, ISMP or Quarterwatch , is an invaluable independent non-profit organization monitoring domestic events of all serious drug reactions reported to the FDA. The Institute has issued a chilling summary for the calendar year of 2011 based on their analysis of reports to the U.S. Food and Drug Administration: An estimated 2 to 4 million persons suffered serious, disabling, or fatal injury associated with prescription drug therapy. This figure is arrived at by the FDA’s own estimate-proven in previous studies over the past decades- that less than 1% of all serious adverse events are reported directly to it. Among the almost 180,000 reported cases in 2011, 88% were collected, written, and submitted by drug manufacturers, and only 12% were submitted directly to the FDA by health professionals and patients. “Many factors influence manufacturer reporting of adverse events. A company actively marketing a brand name drug may learn of adverse events when its sales force calls on physicians, and through consumer hotlines and assistance programs. On the other hand, the multiple manufacturers of a generic drug have little contact with physicians and patients and seldom learn of events to report. This and other variability is avoided with direct reports to the FDA because all events can be reported to a single FDA web site or 800 number, 1-800-332-1088 for OTC drugs. See FDA.gov
Using 2011 report totals suggests that there would have been an estimated 2 million or more cases of serious injury, including 128,000 patient deaths. The most frequently identified drugs in direct reports to the FDA were the anticoagulants dabigatran (PRADAXA) and Warfarin (COUMADIN), showing that inhibiting clotting ranks among the highest risk of all drug treatments. In addition, they “identified nine other drugs associated most frequently with five clinically relevant, drug-related injuries, and show the drugs most frequently the target of lawsuits.” Additional “top” drugs include LEVOFLOXACIN (LEVAQUIN), CARBOPLATIN, LISINOPRIL, ZESTRIL, Reglan (Metoclopramide) and 350 other drugs.
FDA is looking at whether bleeding is happening more frequently than should be expected with Pradaxa which is in the newer medication class of thrombin inhibitors. There is no rapid current method of stopping bleeding caused by this drug. Thus, one of the major Pradaxa side effects is serious bleeding which cannot be stopped.