Issue: January 2012
January 01, 2012
1 min read

Safety review of dabigatran under way

Issue: January 2012
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The FDA today announced an ongoing safety review of dabigatran, prompted by postmarketing reports of serious bleeding.

The review will determine whether reports of severe bleeding in patients taking dabigatran (Pradaxa, Boehringer Ingelheim) submitted to the Adverse Events Reporting System database are occurring more commonly than would be expected, based on observations in the large clinical trial that supported approval of the drug. In the trial of more than 18,000 patients, major bleeding events occurred at similar rates in patients assigned to dabigatran vs. patients assigned to warfarin, according to a safety communication issued by the agency.

“At this time, [the] FDA believes the benefits of Pradaxa continue to exceed the potential risks when the drug is used appropriately following the approved drug label. [The] FDA recommends that health care professionals continue to prescribe Pradaxa following the recommendations in the drug label,” according to the statement.

Patients with atrial fibrillation should not stop taking dabigatran without first consulting a health care professional, according to the agency.

The FDA and Boehringer Ingelheim are working together to analyze postmarketing reports for evidence of inappropriate dosing, use of interacting drugs or other clinical factors that may lead to a bleeding event. The agency will communicate new information on the risks for bleeding with dabigatran as it becomes available. Health care professionals and patients are encouraged to report adverse events or effects related to the use of dabigatran to MedWatch.

Dabigatran is approved to reduce the risk for stroke in patients with nonvalvular AF. The drug label currently contains a warning about significant and sometimes fatal bleeds.

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