(May 24, 2012) – Pradaxa, a blood thinning drug which the U.S. Food and Drug Administration (FDA) is investigating for causing serious, possible fatal bleeding in patients. Doctors prescribe Pradaxa to help reduce strokes and prevent blood clots in patients diagnosed with atrial fibrillation (AFib), sometimes referred to as an irregular heart beat. This drug has been linked to bleeding so severe that it can cause heart attacks and possibly result in death. Pradaxa is manufactured by Boehringer Ingelheim Pharmaceutical GmbH & Co. KG of Germany.
The FDA issued a safety alert regarding Pradaxa in December 2011. The FDA is conducting a safety review of reports of serious bleeding related to taking Pradaxa. Health agencies in Europe, Japan and New Zealand have also reported cases of severe and sometimes fatal bleeding, which may have been caused by Pradaxa. The drug was introduced as an alternative to warfarin, a commonly used anti-coagulant. However, unlike warfarin, severe bleeding caused by Pradaxa cannot be stopped by injections of vitamin K. In addition, there are no good antidotes for bleeding caused by Pradaxa. More than two million Americans have atrial fibrillation, which makes them prone to blood clots, which can cause strokes. Lawsuit claims against drug makers allege that the company failed to completely research its side effects and promoted it as a safe alternative to warfarin. Warfarin (Coumadin) is an established medication that has a reversal agent if bleeding problems occur. These lawsuits also allege that the manufacturer failed to adequately warn about Pradaxa’s lack of any reversal agent. In any case, Boehringer Ingelheim promoted its blood thinners as a more convenient alternative to warfarin because it requires less monitoring.
Pradaxa is relatively new to the market, being approved by the FDA in October 2010. Pradaxa is used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. From its approval until August 2011, approximately 1.1 million Pradaxa prescriptions were dispensed to 371,000 patients. There have been 250 deaths associated with Pradaxa as reported in the Bloomberg News.
Pradaxa has serious side effects to be concerned about. Serious bleeding incidents may occur in patients, even after minor injuries like a fall or bump to the head, which is a well-known complication of all anti-coagulant therapies. In addition, a study done in January 2012 showed that Pradaxa patients had a 33 percent greater chance of heart attack or severe heart disease symptoms than those taking warfarin. Patients taking Pradaxa are also warned that bruising may occur more easily and take longer for the bleeding to stop. Patients are instructed to seek immediate care from a doctor if any signs or symptoms of bleeding are noticed:
– unexplained bleeding from the gums
– frequent nose bleeds
– heavier than normal menstrual or vaginal bleeding
– severe or uncontrollable bleeding
– unexplained bruises that grow in size
– coughing up blood or blood clots
– vomiting blood or vomit that looks like coffee grounds
– urine that is pink or brown
– stools that are red or black and look like tar
The FDA is working with the manufacturer to analyze post market reports to identify possible evidence of inappropriate dosing, drug interactions or other clinical factors that might lead to uncontrollable bleeding.
Before patients discontinue use of Pradaxa they should discuss with their doctors. Stopping the use of blood thinning medications can increase the risk of stroke, leading to permanent disability or death.