Rivaroxaban (Xarelto) Also a Focus of FDA's Safety Monitoring Service

Shelley Wood

January 15, 2014

BETHESDA, MD – The FDA's active safety surveillance agency has announced it has developed a prospective surveillance plan for the novel oral anticoagulant rivaroxaban (Xarelto, Bayer Pharma/Janssen Pharmaceuticals). The first indication that the FDA's Mini-Sentinel Operations Center was developing a surveillance protocol for the drug came earlier this week, when a request for public comment appeared on the Mini-Sentinel website[1].

A project manager with the program confirmed that development of the protocol has been under way over the past several months, but these plans are typically not made public until they are opened for comment.

The public comment period is now open until January 27, 2014.

According to the description of the Prospective Routine Observational Monitoring Programming Tools (PROMPT) posted January 13, 2014, the working group plans to prospectively collect information on "selected safety outcomes (ischemic stroke, intracranial hemorrhage, and gastrointestinal bleeding) in adults with atrial fibrillation who are new users of rivaroxaban, with warfarin as the comparator."

Earlier this month, heartwire reported that the FDA is also requesting public comment on a proposed study, also using data from the Mini-Sentinel Distributed Database, to "assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of dabigatran [Pradaxa, Boehringer Ingelheim] and warfarin for patients with atrial fibrillation."

Whereas the dabigatran project is a customized study protocol that will look retrospectively at data already collected in the database, the rivaroxaban surveillance project will use standardized tools, already developed, to track data prospectively, Mini-Sentinel program manager Susan Forrow explained.

Dr Elizabeth Chrischilles (University of Iowa College of Public Health, Iowa City) is leading the working group for this PROMPT.

The Mini-Sentinel is part of the FDA's broader Sentinel program that monitors market-approved products. Launched in 2009, the Mini-Sentinel enables the agency to query privately held electronic healthcare data (including administrative claims and clinical data) representing approximately 60 million patients, the website explains.

Asked to comment on the Mini-Sentinel announcement, a spokesperson for Janssen said: "We are continuously assessing the benefit/risk profile of Xarelto across all indications, and to date the postapproval safety profile is consistent with the phase 3 clinical trials and completed postmarketing studies."

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