Safety Review Ordered for Pradaxa

Pradaxa/ Blood Clots/ Blood Thinners

The U.S. Food and Drug Administration announced this week that it will conduct a complete safety review of the drug, Pradaxa (dabigatran), following reports that it may cause excessive bleeding. Pradaxa is an oral direct thrombin inhibitor that is used to prevent stroke in patients suffering from nonvalvular atrial fibrillation. The FDA’s safety review announcement [...]

Public Citizen Speaks Out Against Approval of Stroke Drug

Xarelto

The consumer watchdog group, Public Citizen, this week asked the U.S. Food and Drug Administration not to approve the drug, rivaroxaban (Xarelto), for use in patients with atrial fibrillation, citing concerns over the drug’s overall safety and efficacy. The group issued a letter to the FDA, specifically addressing a recent discrepancy in opinion between an [...]