Recall for Pradaxa Not Recommened by European Medicines Agency

Austin Kirk

By Austin Kirk
Posted May 29, 2012


In recent months, there have been mounting concerns over the risks associated with side effects of Pradaxa, as health officials in the U.S., Canada and Europe were continuing to review reports involving serious bleeding problems and deaths among users of the anticoagulant.

According to a statement issued on Friday by the European Medicines Agency (EMA) a recall for Pradaxa will apparently not be recommended in the European Union, but the drug maker will be forced to provide stronger warnings and clearer guidance for consumers and the medical community.

In a press release issued last week following a Pradaxa review conducted by the EMA’s Committee for Medicinal Products for Human Use (CHMP), the European regulatory agency indicated:

On the basis of available evidence, the CHMP concluded that the benefits of Pradaxa continue to outweigh its risks and it remains an important alternative to other blood-thinning agents. However, the advice to doctors and patients should be updated and strenthened to give clearer guidance on the best use of the medicine. This includes more specific guidance on when Pradaxa must not be used as well as advice on managing patients and reversing the anticoagulant effect of Pradaxa if bleeding occurs.

Pradaxa (dabigatran) was introduced in the United States by Boehringer Ingelheim in October 2010, as a superior alternative to Coumadin. However, within the first two years on the market, hundreds of adverse events were reported involving serious Pradaxa problems, including cases of hemorrhages and bleeding that resulted in death.

The EMA, which is the equivalent to the FDA for the European Union, indicates that a review of all available data suggests that the frequency of fatal bleeds with Pradaxa in post-marketing data is significantly lower than what was observed in clinical trials used by the drug maker to obtain approval to market the drug, but that the issue should continue to be kept under close surveillance and that stronger warnings and information are needed to protect patients who are taking Pradaxa.

According to Questions and Answers about the Pradaxa review (PDF) provided, the following are some of the points that the EMA has recommended be clarified and strengthened include:

  • Details on specific situations where Pradaxa must not be used
  • Identifying the types of lesions or conditions and other medications that may put patients at significant risk of major bleedings
  • Details on how kidney function should be assessed for patients considering Pradaxa and during treatment if deterioration is suspected
  • Information on options for managing patients and reversing the side effects of Pradaxa if bleeding does occur
  • Indication that patients taking other anticoagulants (medicines to prevent blood clotting) must not take Pradaxa, except during a period where their treatment is being switched to or from Pradaxa
  • Indication in the package insert that patients should seek urgent medical attention if they fall or injure themselves while taking Pradaxa, especially if they hit their head, due to the increased risk of bleeding

In the United States, the FDA issued a drug safety communication in December 2011, to indicate that the agency is evaluating post-marketing reports of serious bleeding problems with Pradaxa, including a number of deaths. Recommendations or other regulatory actions in the United States have not been finalized, although most agree that it is unlikely the FDA will require a recall for Pradaxa, and will likely recommend stronger warnings for consumers as well.


The Pradaxa lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing a lawsuit against Boehringer Ingelheim as a result of their failure to provide adequate information to consumers or the medical community about the risk of serious bleeding events. Financial compensation may be available through a Pradaxa lawsuit for individuals who have experienced:

  • Internal Bleeding or Gastrointestinal Bleeding
  • Brain Hemorrhage
  • Kidney Bleeding
  • Heart Attack
  • Death


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