Pradaxa Linked to Heart Attack

Pradaxa® is a relatively new blood thinner prescribed to prevent stroke in patients suffering from atrial fibrillation. Boehringer Ingelheim promotes Pradaxa® as the superior alternative to Warfarin (know as Coumadin) touting its benefits. However, a recent study showed that patients taking Pradaxa® have a much higher risk of heart attack or severe symptoms of heart disease.

Pradaxa® Study — Higher Heart Attack Risk

Based on data from seven clinical trials, the researchers found that patients who take Pradaxa® have a 33% high risk of heart attack. The study concluded that there were serious harmful cardiovascular effects (myocardial infarction and acute coronary syndrome) linked to the use of Pradaxa®. It further urged physicians to consider these potential cardiovascular risks when prescribing Pradaxa®.

Pradaxa® — FDA Safety Review — Serious Bleeding Risk

On December 8, 2011, the FDA issued a safety review to investigate a large number of reports of serious internal bleeding and hemorrhaging related to Pradaxa®. The FDA is investigating to determine if serious reports of bleeding and even death are happening more frequently. This investigation will access the serious bleeding risk associated with Pradaxa®.

On the Web: More Information about Pradaxa®

• Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa®, FDA Drug Safety Communication, 7 Dec 2011
• Dabigatran association with higher risk of acute coronary events, Internal Medicine, 9 Jan 2012
• Study: Higher heart attack risk from Pradaxa®, CBS News, 11 Jan 2012
• Pradaxa - Trading One Problem for Another, 3 Apr 2012