FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Should Restrict Xeljanz and Ban Fenspiride, PRAC Advises

May 28, 2019
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The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended limiting prescriptions of Xeljanz and cancelling fenspiride’s marketing authorization, citing safety concerns.

The committee said doctors should temporarily stop prescribing the 10mg twice daily dose of Pfizer’s Xeljanz (tofacitinib) for patients at high risk of blood clots in the lungs. The Janus kinase enzyme inhibitor is used to treat rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.

The committee’s concern follows an FDA alert nearly three months ago warning that a safety trial found an increased risk of blood clots in the lungs and death in rheumatoid arthritis patients taking the 10mg dose—double the recommended dose for the disorder.

The committee also recommended withdrawing the marketing authorization for cough medicines that contain fenspiride after a review determined they could cause heart rhythm problems. The move would bar the drugs from being sold in the EU.

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