Canadian health organization, Health Canada became the second regulatory agency to issue a Pradaxa side effects warning last week about the health risks associated with the blood thinner for patients who have artificial (also known as prosthetic) heart valves.

This particular demographic is especially at risk for suffering strokes, Pradaxa bleeding, blood clots and other side effects, the Dec. 21 warning stated.

Health Canada said it is currently working with the drug’s maker, Boehringer-Ingelheim, to adjust the Canadian Product Monograph to say the blood thinner should not be prescribed to patients who have had prosthetic heart valve replacements. Right now, the Pradaxa side effects label only includes a strong recommendation by the company against doing so.

The announcement by Health Canada was made just two days after the U.S. Food and Drug Administration (FDA) issued a similar Pradaxa side effect warning, in which they said the drug’s maker, Boehringer Ingelheim, would be adjusting the blood thinner’s label in the U.S. to say it should not be prescribed to those who have prosthetic heart valves.

 To ensure the message is received by the medical community, the FDA’s Dec. 19 alert also stated that Boehringer-Ingelheim plans to send a “Dear Doctor Letter” to all health care providers to inform them of the change.

Many patients in the U.S. have already filed claims over the blood thinner in a mounting number of Pradaxa lawsuits. According to a recent report from, 150 Pradaxa lawsuits have already been brought by plaintiffs who allegedly sustained excessive Pradaxa bleeding after taking the drug, and are currently pending in a federal multidistrict litigation (MDL) based in the U.S. District Court, Southern District of Illinois.

Meanwhile, the FDA has received 3,781 adverse event reports of Pradaxa side effects, and 542 deaths potentially tied to the drug.

Published January 2, 2013 by