Pradaxa Lawsuits

Pradaxa Lawsuits

Serious side effects have been reported including:

• Death
• Internal bleeding
• Unusual bruising or bleeding / hemorrhaging
• Cerebral hemorrhaging
• Nose bleeding that happens often
• Bleeding that is severe or you cannot control
• Pink or brown urine
• Vomiting blood or vomit that looks like coffee grounds.
• Unusual bleeding from the gums
• Red or black stools (looks like tar)
• Menstrual or vaginal bleeding that is heavier than normal
• Bruises that happen without a known cause or that get larger
• Coughing up blood or blood clots

The makers of Pradaxa are heavily promoting their new drug as the new and improved alternative to warfarin – the standard front line therapy for those suffering from AFib for more than 50 years. However, unlike Pradaxa, the risk and benefits of warfarin have been rigorously studied and are well understood by doctors and patients alike. While numerous studies have established warfarin as safe and effective, Pradaxa has only one. While this one study appeared to support Pradaxa’s miracle claim of 35% reduction in strokes compared to warfarin – the study also revealed a troubling fact about Pradaxa – a statistically significant increase risk of gastrointestinal bleeding in those taking Pradaxa compared to those on warfarin. The makers of Pradaxa argue this increased risk of bleeding is outweighed by the decreased risk of stroke. Doctors and regulators are starting to question whether this is true. While the makers of Pradaxa claim a 35% stroke risk reduction – this is the relative risk reduction. The absolute risk reduction – the actual decrease in the numbers of strokes in patients on Pradaxa is a paltry 0.2%. That is not a typo – 0.2% - and that is accepting the results of the single study at face value. The face value of the study is very much in doubt as well. The study was plagued with data integrity errors, its design is subject to bias and no less than 18 of the 20 named authors reported a financial conflict of interest with the makers of Pradaxa. Making matters even worse is the fact that Pradaxa has no known reversal agent. Again – this stands in stark contrast to warfarin which can be reversed in the event of an emergency or bleeding event. It is no wonder more than 250 deaths as a result of bleeding events have been reported in users of Pradaxa.

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Resources

• FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)