Drug Safety Update
April 2023: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
 January 2015: Ustekinumab (Stelara): risk of exfoliative dermatitis
  April 2014: There is an increased risk of tuberculosis, or reactivation of latent tuberculosis, during treatment with tumour necrosis factor alpha (TNF-alpha) inhibitors. TNF-alpha inhibitors are contraindicated in patients with active tuberculosis or other severe infections.
Infliximab is approved for the treatment of ulcerative colitis/Crohn's disease when prescribed according to NICE TAs (see links attached to drugs below). It is also approved for the management of diarrhoea or colitis related to immune checkpoint inhibitor (ICPI) therapy (unlicensed indication).
The JAK inhibitors upadacitinib, tofacitinib and filgotinib are all approved for the treatment of ulcerative colitis and upadacitinib for treating moderately to severely active Crohn’s disease in adults in accordance with NICE TAs (see NICE links attached to drugs). They are for specialist use only.
Risankizumab is approved for previously treated moderately to severely active Crohn's disease in people 16 years and over in accordance with NICE TA 888 (see link next to drug below).
Mirikizumab is approved for treating moderately to severely active ulcerative colitis in accordance with NICE TA 925 (see link next to drug below).
