Taking into account the available data on risk (s) from the literature and spontaneous reports, including in some cases a close temporal relationship, positive challenge-response, and/or re-challenge, PRAC consider that
– the relationship between 5-fluorouracil (IV) and cutaneous lupus erythematosus
– the relationship between 5-fluorouracil (IV) and stress cardiomyopathy (takotsubo syndrome)
– the relationship between 5-fluorouracil (IV) and intestinal pneumatosis
– the relationship between 5-fluorouracil (IV) and posterior reversible encephalopathy syndrome (PRES)
– the relationship between 5-fluorouracil (i.v.) and lactic acidosis
– the relationship between 5-fluorouracil (i.v.) and tumor lysis syndrome
are at least possible. Changes to the SMPC should be made.