Patients taking the anticoagulant dabigatran (Predaxa) should continue with the medication as prescribed despite reports that the drug can cause severe bleeding, the FDA has announced.
The FDA has announced that it is evaluating post-marketing reports of serious bleeding in patients taking the drug after reports of fatal bleeding.
Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies, the FDA said.
The drug's label warns of fatal bleeding, but the FDA said the agency at this time 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.
A report was published in early November raising concerns of Pradaxa bleeding deaths, suggesting that about 50 deaths from bleeding in atrial fibrillation patients has raised concern, but the drug's manufacturer said the safety profile is where it should be, according to a story published in MedPage Today.
The drug's manufacturer has maintained, however, that Pradaxa's safety profile is on solid ground.
The clinical effectiveness and favorable safety profile of Pradaxa is positive and remains unchanged in light of recent reports about fatal cases of bleeding in the media, Boehringer Ingelheim said in a statement.
The FDA said in its Dec. 7 statement that patients should not stop taking the drug without consulting a physician first since that could increase the risk of stroke. Physicians and healthcare professionals have been advised to report any side effects or adverse events related to Pradaxa use to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.