FDA Alerts on Increased Risks Linked to Pfizer’s Xeljanz

Regulatory NewsRegulatory News | 26 February 2019 |  By 

The US Food and Drug Administration (FDA) alerted the public late Monday of a post-marketing safety clinical trial for Xeljanz (tofacitinib) that found an increased risk of lung blood clots and death in patients with rheumatoid arthritis (RA) who were taking a dose of 10 mg twice daily.

The drug safety communication noted the increased risk was observed in the post-marketing trial set as a requirement on Pfizer following the first approval of Xeljanz in 2012. It comes after a string of subsequent approvals that Pfizer’s Xeljanz has obtained since then, including the 2017 approval for the treatment of psoriatic arthritis.

The 2012 FDA approval required Pfizer to conduct a trial among patients with RA who are at least 50-years-old and have a minimum of one cardiovascular risk factor to evaluate the approved dose of 5 mg twice daily and the unapproved 10 mg twice daily dose. This risk evaluation involved use of Xeljanz in combination with methotrexate when compared to another drug, known as a tumor necrosis factor inhibitor. Pfizer’s drug safety monitoring board identified the safety signal of pulmonary embolism and increased overall mortality in the patient treatment group that received Xeljanz or Xeljanz XR at the 10 mg twice daily regimen during the board’s most recent analysis.

In response to the board’s finding, FDA recommended a study modification. Pfizer issued a notice earlier this month to inform of its decision to transition patients who had been given the 10 mg twice daily dose to the currently approved dose of 5 mg twice daily as part of the manufacturer’s ongoing safety trial of Xeljanz. “This trial will continue and is expected to be completed by the end of 2019,” FDA noted.

In reaction to FDA’s drug safety communication, Pfizer spokesperson Neha Wadhwa said the company continues “to evaluate the risk benefit profile of tofacitinib across all indications and we will continue to work with regulators as more data become available.”

The agency clarified it continues to believe that the benefits of taking Xeljanz of Xeljanz XR for approved uses continue to outweigh the potential risks. It recommended health care providers follow Xeljanz' prescribing information specific to the condition they are treating and monitor pulmonary emobolism signs and symptoms.

“Today’s safety alert underscores the importance of monitoring and addressing safety questions that arise in the postmarket setting,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said.



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