(RxWiki News) U.S. Food and Drug Administration officials are taking a second look at blood thinning drug Pradaxa (dabigatran etexilate mesylate) after reports of serious, potentially fatal, bleeding.
FDA officials will evaluate the post-market reports to determine whether serious bleeding is more common than anticipated, though serious bleeding is a known complication of all anticoagulant therapy.
About 50 cases of fatal bleeding have been reported worldwide since November.
"Take Pradaxa as prescribed unless instructed to stop by a doctor."
Pradaxa was designed to reduce the risk of stroke in patients with atrial fibrillation, a common heart arrhythmia. Those with an abnormal heartbeat are at a higher risk of having a stroke.
Drugmaker Boehringer Ingelheim Pharmaceuticals' medication was previously evaluated in two large clinical trials consisting of 18,000 patients prior to its approval by the FDA. During the studies Pradaxa was compared to blood thinner warfarin and it was found that bleeding events tended to occur at similar rates for both drugs.
Pradaxa already carries a warning label that mentions the risk of serious and sometimes deadly bleeding.
FDA officials have advised that patients should not stop taking the drug without speaking to their physician. Stopping the use of blood thinners can increase the risk of stroke.
In a statement, the FDA said it "continues to believe that Pradaxa provides an important health benefit when used as directed, and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label."
Doctors are asked to report adverse events or side effects related to use of the drug to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
