Increased risk of diverticulitis + GI perforation with baricitinib
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Increased risk of diverticulitis + GI perforation with baricitinib Baricitinib (Olumiant) is linked with cases of diverticulitis and gastrointestinal perforation, and should be used with caution in at-risk patients, says the UK’s MHRA.* First authorised in the EU in February 2017, Olumiant (a Janus kinase inhibitor) is approved for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or are intolerant to, one or more DMARDs. This medicine is also classified as a "black triangle medicine", indicating that this medicine is subject to additional monitoring following market launch. The regulatory agency recently issued advice for healthcare professionals regarding this safety concern, following a review of cases in clinical trials and from postmarketing surveillance. Baricitinib should be used with caution in patients with pre-existing diverticular disease, as well as in patients receiving long-term concomitant medications associated with an increased diverticulitis risk (e.g. NSAIDs, corticosteroids, opioid analgesics). Healthcare professionals should advise their patients to seek immediate medical attention if they experience severe abdominal pain – particularly when accompanied with fever, nausea and vomiting, or other diverticulitis symptoms. Furthermore, healthcare professionals should "ensure prompt evaluation of any patients on baricitinib who present with new-onset abdominal signs and symptoms to identify early diverticulitis or gastrointestinal perforation", said the MHRA. Any suspected adverse reactions to black triangle medicines should be reported to the MHRA via its Yellow Card scheme. * MHRA = Medicines and Healthcare products Regulatory Authority Medicines and Healthcare products Regulatory Agency (UK). Baricitinib (Olumiant): increased risk of diverticulitis, particularly in patients with risk factors. Internet Document : 26 Aug 2020. Available from: URL: https://www.gov.uk/drug-safety-update/baricitinib-olumiant-increased-risk-of-diverticulitis-particularly-in-patients-with-risk803501793 factors
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Reactions 12 Sep 2020 No. 1821
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