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  • FDA and EMA warn patients taking high dose of Xeljanz
  • by Nho, Byung Chul | translator Byun Kyung A | Nov 19, 2019 06:34am
EMA bans 10mg twice-daily maintenance on ulcerative colitis at high risk of blood clots
FDA removes Xeljanz from first-line ulcerative colitis indication, pushes down to second-line
MFDS and Pfizer Korea in talks for patient-safety-first action to take
The European Medicines Agency (EMA) has decided to limit high dose prescription of a Janus kinase (JAK) inhibitor medicine, Xeljanz (tofacitinib citrate), following a similar move by the U.S. Food and Drug Administration (FDA), and now Korean Ministry of Food and Drug Safety (MFDS) is also expected to make a similar decision in response.

On Nov. 15 (local time), EMA officially confirmed that the maintenance therapy taking 10mg twice daily should not be used in patients with ulcerative colitis who are at high risk of blood clots unless there is no suitable alternative treatment.

Previously, EMA¡¯s safety committee, also known as Pharmacovigilance Risk Assessment Committee (PRAC), issued a statement in last Ma
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