The Institute for Safe Medication Practices released a report on the drugs most commonly reported to the Food and Drug Administration (FDA) for serious or fatal adverse reactions. Topping the list for 2011 was the drug Pradaxa, manufacturer by German pharmaceutical company Boehringer Ingelheim.
The reports of adverse reactions are sent directly to the FDA from either the manufacturer, healthcare practitioners, or consumers.
In fact, Pradaxa had more than three times the reported adverse effects as any other drug in 2011. Of the thousands of Pradaxa reports, over 500 were for deaths sustained from Pradaxa use. Pradaxa not only lead all other monitored drugs for reported deaths, but also was the most reported for bleeds, kidney failure, and stroke.
Pradaxa, a blood thinner, has been linked to gastrointestinal issues, increased risk of heart attack, and fatal bleeding. Recent reports now indicate that Boehringer Ingelheim may not have been forthright in conducting and reporting studies used in the FDA approval of Pradaxa.
Doyle Raizner is currently investigating reports of serious adverse effects resulting from Pradaxa use and potential recovery for victims.
More information on the study is available here.