Eliquis earns best safety score in its class in analysis of FDA adverse event reports

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What's the safest anticoagulant? According to AdverseEvents, which analyzes and distills data filed with the FDA, that would be Eliquis, the latest entrant into the warfarin alternative market.

After running adverse event reports filed with the FDA through its filters and algorithms, AdverseEvents found Eliquis (apixaban) to be significantly safer than its rivals. Marketed by Bristol-Myers Squibb ($BMY) and Pfizer ($PFE), the drug showed up with an "RxScore"--the data firm's scale of safety--of 39.45 on a 100-point scale, with 100 representing the highest risk.

The FDA's database of adverse events comprises all the reports made by doctors, patients and other healthcare providers, so it's not a scientific collection. The reported side effects aren't necessarily caused by the drug or drugs a particular patient takes. But they did surface during or after treatment, and prompted someone to file a report. AdverseEvents applies logic, math and software to the database in an attempt to sift out the important data.

The key safety risk with clot-fighting medications is bleeding. Warfarin alternative drugs have an advantage over warfarin in that they don't require the same sort of dietary vigilance and theoretically don't require constant monitoring to make sure dosing is correct. But since their advent, with the approval of Boehringer Ingelheim's Pradaxa, safety questions have cropped up, particulary because they as yet have no proven antidotes to reverse bleeding if it happens.

For Eliquis, the rate of suspect cases was lower in every type of adverse-event report, from hospitalization to death, AdverseEvents explains in its report, "Examining the Comparative Safety of Blood Thinners." For example, among Eliquis patients reporting side effects, only 21% cited hospitalization, while Pradaxa had 39%, Xarelto 43% and warfarin 50%.

Overall, in last place in the anticoagulant class was warfarin, once the standard treatment to prevent stroke in patients with atrial fibrillation and clotting in certain other circumstances. It ended the analysis with a score of 67.56. Both Pradaxa (dabigatran) and Bayer and Johnson & Johnson's ($JNJ) Xarelto (rivaroxaban) fared a little better, at 67.15 and 67.08 respectively.

"Our review of post-approval data suggest disproportionally elevated reporting of certain adverse events such as various hemorrhagic, embolic, and thrombotic events linked to the use of blood thinners," the AdverseEvents report states. "The results ... all point to the same general conclusion: Apixaban may be a safer choice within the anticoagulant class."

- get the report link here

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