Q. What did the British Medical Journal article say about dabigatran/Pradaxa and its manufacturer?

The journal released a report questioning whether drugmaker Boehringer-Ingelheim fully disclosed all it knew about how doctors could possibly lower the risk of bleeding side effects of Pradaxa by measuring blood levels or the anti-clotting effects of the drug in patients.

The company said the journal’s story was misleading and inaccurate.

Q. Did the FDA know about the bleeding side effects of Pradaxa when it approved the drug?

Yes. The FDA approved the drug based on the research and safety data it had at the time. This included information about the risk of bleeding with dabigatran/Pradaxa. The FDA’s approval did not require blood monitoring of patients taking dabigatran; such monitoring is required for the drug warfarin.

Q. What is warfarin?

Warfarin is a drug that inhibits blood clotting. It has been used to treat atrial fibrillation patients since the 1950s and is less costly than newer drugs. It requires frequent, usually monthly, blood monitoring to determine whether adjustments to the prescribed dose are necessary.

Q. Why would patients taking warfarin want to switch to a drug known to cause bleeding?

All anti-clotting drugs, including dabigatran and other similar drugs and older drugs like warfarin, can cause gastrointestinal, brain or other bleeding. There is also a chance that patients who take these drugs could still have a stroke, because the drugs do not provide perfect protection against stroke. However, the chance is greatly reduced.  The large research trial of dabigatran, known as RE-LY, and additional analysis found no greater bleeding risk with dabigatran than with warfarin.

Q. What does the American Heart Association recommend regarding the use of dabigatran/Pradaxa?

The AHA, along with the American College of Cardiology and the Heart Rhythm Society, recommended considering dabigatran and other drugs in its class as alternatives to warfarin for patients who have non-valvular atrial fibrillation and stroke risk factors, or when warfarin does not result in therapeutic blood test (INR) levels. The association does not recommend dabigatran for people with a mechanical heart valve, significant heart valve disease, severe renal failure or advanced liver disease.

Q. Will AHA recommend blood monitoring?

The AHA will continue to monitor published research on dabigatran and drugs like it, and make updates as necessary. The blood test by has real investigators to assess blood levels of ndabigatran and its efficacy against clotting is not yet approved for use in the United States. The association would also consider any specific actions taken by the FDA. This monitoring and reevaluation process is the same for all AHA guidelines and recommendations.