A multicenter study on drug safety in children [Studio multicentrico sulla sicurezza dei farmaci in pediatria]

Objective: An active surveillance system to estimate adverse drug and vaccine events in children is coordinated by the National Institute of Health in Italy. The study is conducted in some Italian paediatric hospitals and departments. Methods: The study includes children hospitalised through the Emergency Department for thrombocytopenia, esophageal and gastroduodenal lesions, neurological disorders, muco-cutaneous diseases. Drug exposure is retrieved through interview to parents. The association between drugs (or vaccines) and events is estimated with a case-control study design. Results: 2,887 children hospitalised have been enrolled from November 1999 to June 2006. A 2.2 risk of thrombocytopenia has been associated with antibiotics. An increased risk associated with MMR vaccine has been confirmed (OR 2.7). An increased risk of non febrile seizures has been associated with hexavalent vaccines (OR 2.7). Conclusion: The study confirmed and quantified recommendations coming from the spontaneous reporting system and it is an important support for the Italian national pharmacovigilance.