FDA launches Pradaxa side effects investigation
The Food and Drug Administration has launched an investigation into the anticoagulant Pradaxa after receiving reports of severe bleeding among patients taking the drug. At least 260 deaths caused by excess bleeding have been reported among patients who were using Pradaxa.
Pradaxa was approved by the FDA in October 2010 for the prevention of stroke in patients with an irregular heartbeat. Although the drug has fewer interactions than warfarin—another anticoagulant drug—Pradaxa has no reversal agent or antidote that can stop severe bleeding among patients who develop complications due to treatment.
The FDA investigating cases of serious bleeding linked to Pradaxa in order to determine if these are occurring at a higher rate than would be expected with anticoagulant drugs. Despite its Pradaxa side effects investigation, the FDA has not announced any plans to recall the drug due to its serious bleeding risk.
The FDA has advised patients who are taking Pradaxa to speak with their doctor if they have concerns about the side effects of the drug. Symptoms of excess bleeding caused by Pradaxa may include nose bleeds, pink or brown urine, vomiting blood, red or black stool, coughing up blood or other signs of visible bleeding.