Pradaxa Bleeding Risks Result in EMA Call For New Guidance

European health officials have determined that clearer guidance is needed for doctors and patients about how to use the anticoagulant Pradaxa and reduce the risk of serious and potentially life-threatening bleeding problems, which have raised concerns since the medication was approved.

In a statement issued by the European Medicines Agency (EMA) on May 25, the regulatory agency for the European Union indicated that while the bleeding risks associated with Pradaxa side effects appear to be outweighed by the benefits provided by the medication, meaning that the medication does not need to be recalled. However, the agency recommended that stronger warnings and information should be provided about the best use of the medication, including more specific guidance on when Pradaxa should not be used and how to manage bleeding problems that do occur.

Pradaxa (dabigitran) is marketed by Boehringer Ingelheim as an alternative to Coumadin (warfarin) for prevention of stroke among patients with atrial fibrillation. 

Although the medication has been promoted as superior and easier to use, because it requires less monitoring, Pradaxa does not have an easy reversal agent that can be used to quickly stop bleeding problems that may develop.  While doctors can give patients taking warfarin a dose of vitamin K if bleeding problems occur, no such antidote is available to address bleeding that may develop while on Pradaxa.

Since the medication was introduced in the United States in October 2010, concerns have increased about the Pradaxa bleeding risks amid hundreds of adverse event reports involving uncontrollable hemorrhages and bleeding events, which have caused a higher-than-expected number of deaths.

Following an assessment of all available data, including post-marketing reports involving serious or fatal bleeds on Pradaxa, the EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that the medication remains an important alternative to other blood-thinning agents, but determined that the advice to doctors and patients should be updated and strengthened to give clearer guidance on the best use of the medicine.

New information will be provided for healthcare providers with more specific guidance on when Pradaxa should not be used, as well as stronger warnings for patients that if they fall or injure themselves during treatment, especially if they hit their head, they should seek urgent medical attention.

In the United States, Boehringer Ingelheim faces a growing number of Pradaxa lawsuits brought on behalf of individuals who have experienced problems, alleging that the drug maker failed to adequately warn consumers and the medical community about the serious and potentially life-threatening bleeding risks with Pradaxa use.

A Pradaxa safety investigation into the reported bleeding problems and deaths is still underway in the U.S. by the FDA.