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According to date released by QuarterWatch–an Institute for Safe Medication Practices program that monitors reported serious and fatal adverse drug events–the FDA received 179,855 reports of serious or fatal adverse drug reactions in 2011. This figure represents a 9.4 percent increase from reports received in 2010.

The FDA receives reports in two ways: voluntary reports from health care providers and/or patients, and reports from the pharmaceutical manufacturers.  Of the 2011 reports, 21,002 were voluntary reports and 158,853 were reported by the manufacturer.  Drug makers are required to report serious drug reactions within 15 days of becoming aware of the reaction.

The top 10 drugs with the greatest number of reports are: Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro, and Bactrim.  These dangerous drugs include some of the most widely prescribed drugs currently on the market. There were 3,781 reports regarding Pradaxa including 542 deaths, 2,367 hemorrhages, 291 acute renal failure and 644 strokes. Pradaxa was also suspected in 15 cases of liver failure.

It is widely accepted that only about 1 percent of serious drug reactions are reported to the FDA. Based on this statistic and the 179,855 events that were reported, there may have been as many as 18 million serious or fatal adverse drug reactions last year.

For more information on the dangers of Pradaxa, contact the Ohio Pradaxa lawyers at Clark, Perdue & List. 

Source: Philadelphia Inquirer, “Drugs most frequently reported for adverse reactions,” Michael R. Cohen, June 6, 2012.