According to data recently released from QuarterWatch, an Institute for Safe Medication Practices surveillance program which monitors all serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration through Medwatch, in 2011 the FDA received 179,855 reports of serious or fatal adverse drug reactions. This was an increase of 15,386 reports (9.4 percent) from the 2010 total. Moreover, of the ten drugs with the largest number of reports sent directly to the FDA by healthcare practitioners and consumers in 2011, Pradaxa side effects surpassed all other monitored drugs in several categories. It received the most number of reports (3,781), deaths (542), hemorrhage (2,367), acute renal failure (291), and stroke (644), while also being suspect in 15 cases of liver failure.
While most drugs resulting in severe side effects, including Pradaxa, often contain some form of FDA-approved warnings, such admonition serves merely as the first step in the process of managing risks. When combined with the general drug world consensus which contends that only about 1 percent of serious events ever get reported to the FDA, it is evident that stricter measures are needed to prevent such undue harm. Boehringer, the manufacturer of Pradaxa, failed to adequately warn about Pradaxa side effects, giving rise to Pradaxa lawsuits across the country.