Back in November, we brought a pair of blog posts to our readers in Alabama about the Food and Drug Administration's opinion of Pradaxa, the anticoagulant blamed by several observers for causing hundreds of deaths and thousands of injuries. As we said then, the FDA has continued to defend Boehringer Ingelheim and the agency's own decision to approve the potentially dangerous product for the U.S. market.
The FDA recently reaffirmed its commitment to keep Pradaxa on the market despite its potentially lethal side effects. In an article published in the most recent issue of the New England Journal of Medicine, the agency called the 542 deaths and 3,781 adverse events linked to Pradaxa in 2011 data that was skewed by over reporting.
According to the article, drugs that are new to the market tend to "elicit adverse-event reports at high rates" that drop as time goes on. Hopefully, the death and injury rate of Pradaxa users will go down on their own or Boehringer will act to improve patient safety, since it does not appear that those are the only ways that atrial fibrillation patients will avoid possible harm from the drug.
One way that Boehringer can reduce the risk of harm associated with Pradaxa would be to develop an antidote. The drug's main competitor for atrial fibrillation patients, warfarin, has vitamin K for an antidote when gastrointestinal bleeding or similar emergencies occur. But Pradaxa does not have an antidote, though that is no problem for the FDA. Boehringer is reportedly working on an antidote.
Source: Drug Watch, "FDA Again Defends Pradaxa, Downplays Lack of Bleeding Antidote," Joey Rosenberg, March 21, 2013