Increased concerns associated with Pradaxa® use

The Food and Drug Administration approved Pradaxa use in October 2010. Shortly after, the agency received a number of reports that the drug causes adverse side effects which are both serious and often fatal.

Pradaxa (dabigatran) is a medication designed to treat patients diagnosed with non-valvular atrial fibrillation. It is included in a class of drugs referred to as direct thrombin inhibitors that work by preventing an enzyme which causes blood to clot. When not treated, blood clots have the tendency to travel through the body to the brain and cause stroke which can in most cases lead to death.  

Increased concerns associated with Pradaxa use caused the FDA to issue a safety communication in December 2011, warning the public and medical community about the risk of injury and other complications associated with Pradaxa.

Reported side effects of Pradaxa include internal bleeding, caused by the drug hindering kidney function leading to an excess of the drug spreading through the system, brain hemorrhaging, kidney bleeding, heart attack, and sometimes death. Of these, internal bleeding is the most serious. Symptoms of internal bleeding are listed on the Pradaxa internal bleeding website.

No recall has yet been issued in the United States on the Pradaxa medication, however, the U.S., Japan, and Australian health officials have issued safety warnings on the drug.

The FDA is also in the process of reviewing a number of claims that Pradaxa causes internal bleeding. In the meantime, Pradaxa lawyers have to represent victims injured by this potentially dangerous drug and are reviewing cases to file against Boehringer Ingelheim, manufacturer of Pradaxa.

Atrial fibrillation is a condition in which part of the heart does not beat the way it should. If not treated properly, blood cells may not circulate properly and tend to clot causing stroke and other complications.


About the Contributor

Related Posts