New patients taking dabigatran (Pradaxa) don’t have higher rates of bleeding than those on warfarin, according to the results of an FDA investigation. Despite that reassurance, patients may ask about a story in the New York Times about the bleeding risks associated with the drug.

The findings of the agency’s safety evaluation are consistent with those from the clinical trial used to approve the drug, says the FDA. However, this may do little to reassure critics who point out that, unlike warfarin, there is no way to reverse dabigatran’s anticoagulant effects. The Times reports that the drug has been linked to over 500 deaths in the U.S.

The FDA says it will continue evaluating “multiple sources of data” as part of an ongoing safety review. In the meantime, dosing recommendations should be carefully followed to reduce the risk for bleeding, especially in patients with renal impairment.

Source: FDA MedWatch safety alert