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5PSQ-082 Third-generation hospital-exclusive cephalosporins: different safety profiles?
  1. B Abreu Faria1,
  2. S Barroso1,
  3. JP Fernandes2,
  4. M Silva2,
  5. A Carvalho1
  1. 1Hospital de Braga, Unidade de Farmacovigilância de Braga, Braga, Portugal
  2. 2Infarmed – Autoridade Nacional do Medicamento e Produtos de Saúde- I.P., Direção de Gestão do Risco de Medicamentos, Lisboa, Portugal


Background and Importance Third-generation cephalosporins are clinically relevant due to their broad spectrum of activity against gram-negative, gram-positive, and Pseudomonas aeruginosa bacteria. Monitoring the safety profile of these medicinal products in a real-world setting is of paramount importance, aiming to protect both individual and collective health. To our knowledge, no study with the aim of comparing the safety profiles of these medicinal products has been conducted in the Portuguese context.

Aim and Objectives Assess the reports of suspected adverse drug reactions (ADRs) received by the Portuguese National Pharmacovigilance System concerning third-generation hospital-exclusive cephalosporins, with the aim of comparing the safety profile of these medicinal products.

Material and Methods A retrospective study was conducted using data from the Portal RAM between 1 January 2013, and 31 March 2023. Individual Case Safety Reports (ICSRs) were selected if they identified only one third-generation hospital-exclusive cephalosporin as the suspect drug, namely cefotaxime (CEFO), ceftriaxone (CEF), ceftazidime (CEFT), or ceftazidime + avibactam (CEFT/AV). Demographic data of the patient, ADR category (MedDRA Preferred Terms (PT)), Important/Designated Medical Event (IME and DME) terms, and case outcomes were analysed.

Results The search returned 269 ICSRs of interest., with the majority related to CEF (84.8%). For all the cephalosporins under study, there was a predominance of male patients, with a median age over 50 years, except for CEFO (15.0±10.0). Most ICSRs were classified as severe (CEFO: 80.0%; CEF: 88.2%; CEFT: 82.4%; CEFT/AV: 64.3%). Regarding the number of ICSRs containing IME terms, CEFT/AV had the highest percentage at 64.3%, while 25.4% of CEF ICSRs contained a DME term. The highest percentage of ICSRs with PT terms related to off-label use and lack of efficacy belonged to CEFT, with 11.8% and 23.5%, respectively. In all cephalosporins, the majority of ICSRs evolved towards recovery.

Conclusion and Relevance Our results appear to indicate that there are no significant differences in the safety profile of these medicinal products. However, further studies are needed. The implementation of active pharmacovigilance protocols at the hospital level may contribute to a safer and more rational use of these drugs, minimising the impact of ADRs on Public Health, both in terms of economic burden on healthcare systems and morbidity and mortality for citizens.

Conflict of Interest No conflict of interest.

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