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Pradaxa Blows Away the Field in 2011 FDA Adverse Drug Events

January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.

2011 was Pradaxa’s first full year on the United States prescription drug market. Last Pradaxa (also known as Dabigatran) generated sales of $829 million dollars in the USA. The drug achieved “blockbuster” status due to such explosive sales. But tragically, sales were not the only area in which Pradaxa was “explosive”.

According to the QuarterWatch publication, Pradaxa far and away lead the number of adversely reported drugs in 2011, more a three-fold increase above the number two drug, Warfarin.

QuarterWatch is an independent publication for the Institute of Safe Medication that monitors adverse drug events reported to the FDA. Here are some general facts from their latest report:

  • In 2011, 2-4 million people suffered serious, disabling, or fatal injury associated with prescription drug therapy./li>
  • In 2011 the FDA received 179,855 reports of these serious, disabling, and fatal drug events, a 9.4% increase from 2010.
  • 88% of these reports were submitted by drug manufacturers, 12% by health care professionals and patients. The FDA estimates less than 1% of all serious adverse reports are reported directly to it.

With regards to Pradaxa, the numbers are staggering. In its first full (and very profitable) year, Pradaxa generated 3,781 domestic and serious adverse reports overall, including 542 patient deaths. It also had 2,367 reported cases of hemorrhage, 291 cases of acute renal failure, and 644 cases of stroke. It also is guessed to cause 15 cases of liver failure. Pradaxa had 817 direct reports, and 2,964 reports from the manufacturer Boehringer Ingelheim.

QuarterWatch’s report bluntly remarks, “We think the FDA, the medical community, and the manufacturer need to reassess the single primary does recommendation for dabigatran (Pradaxa).” This is an understatement, the drug’s adverse effects are skyrocketing at an alarming rate, and the drug has no reversal agent to mitigate any of these effects. It is a chilling thought to contemplate what kind of numbers year 2 of this drug on the market could bring…