In October 2010, the U.S. Food and Drug Administration (FDA) approved Pradaxa capsules (dabigatran etexilate) to prevent stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation). Pradaxa replaced warfarin, an anti-coagulant drug that heart patients have used for decades.
Certainly, Pradaxa has saved lives—patients taking it suffered fewer life-threatening or major bleeds (including intracranial bleeds) than patients using warfarin. But does this mean taking Pradaxa is safe for all patients? Unfortunately, no.