Cefotaxime-related DRESS syndrome

Excerpt

The European Medicines Agency (EMA) has published an overview of recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on a signal for cefotaxime-related drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) which was reviewed by the Committee for Medicinal Products for Human Use (CHMP). PRAC recommendations for updates to the product information for all cefotaxime-containing products by Marketing Authorisation Holders were agreed by the CHMP at their meeting held on 22−25 January 2024.Current text for the Special Warnings and Precautions for use sections of the summary of product characteristics (SMPC) is being replaced with the following information on severe skin reactions: severe cutaneous adverse reactions (SCARs) including acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported postmarketing in association with cefotaxime. Patients should be advised of the signs and symptoms of these skin reactions at the time of prescribing. If signs and symptoms suggestive of these adverse reactions appear, cefotaxime should be withdrawn immediately. If AGEP, SJS, TEN or DRESS is confirmed, cefotaxime should be permanent discontinued. Physicians should consider the possibility of a cefotaxime reaction if children develop a rash and fever during treatment. The Undesirable Effects section of the SMPC is being updated to include drug reaction with eosinophilia and systemic symptoms (DRESS; frequency not known) under skin and subcutaneous tissue disorders.The package leaflet is being updated to warn that patients should not take cefotaxime if they have previously developed a severe skin rash or skin peeling, blistering or mouth sores after taking cefotaxime or other cephalosporins. The warning and precautions section is being updated to warn that serious skin reactions including SJS, TEN, DRESS and AGEP have been reported in association with cefotaxime treatment. In addition, the possible side effects text is being replaced to say that patients should stop using cefotaxime and seek immediate medical attention if they develop symptoms of serious skin reactions including widespread rash, fever and enlarged lymph nodes (DRESS) or other serious skin rashes. …