ABSTRACT
Title
Adverse reactions related to systemic antibiotics: data from the French national pharmacovigilance database.
Authors
F. Salvo (1,2), F. Haramburu (1,3), C. Dumartin (1,4), A. Pariente (1,2,3), A. Fourrier-Réglat (1,2,3), P. Auriche (1,5), G. Miremont-Salamé (1,3) and the network of the French regional pharmacovigilance centres
1 INSERM, U657, Bordeaux, France
2 Université Victor Segalen, Département de Pharmacologie, Bordeaux, France
3 CHU de Bordeaux, Bordeaux, France
4 Centre de Coordination Sud Ouest de lutte contre les infection nosocomial (CCLIN), Bordeaux, France
5 Agence Français de Sécurité Sanitaire des produits de Santé (Afssaps)
1 INSERM, U657, Bordeaux, France
2 Université Victor Segalen, Département de Pharmacologie, Bordeaux, France
3 CHU de Bordeaux, Bordeaux, France
4 Centre de Coordination Sud Ouest de lutte contre les infection nosocomial (CCLIN), Bordeaux, France
5 Agence Français de Sécurité Sanitaire des produits de Santé (Afssaps)
Abstract
Introduction
Antibiotics (ABs) are widely use drugs. However, frequency and pattern of use of the different ABs may change with time. This could induce changes in the frequency and nature of the reported adverse reaction associated to the use of the ABs different classes. In this context, this study aimed at analysing the reports French spontaneous reporting of suspected adverse drug reactions (ADRs) in order to provide updated information concerning the safety profile of systemic antibiotics (ABs).
Methods
Data were retrieved from the French National Pharmacovigilance database from January 2000 to August 2010. Drugs were coded using the Anatomical Therapeutic Chemical (ATC) classification. The ABs were selected according to the ATC code: J01. The ADRs were coded with MedDRA (Medical Dictionary for Regulatory Activities). Seriousness was coded according to the international definition (ICH)
Results
During the studied period, 31,858 cases (51.4% serious) were reported with ABs, which represent 14.4% of the total number of ADRs reports. No difference in age, gender and seriousness were found between ABs and other drugs. Penicillins were the first class of antibiotics in terms of number of reports per year (report/year: 1360), followed by quinolones (881) and cephalosporins (813). Amoxicillin (alone or in association with clavulanic acid) was the most frequently involved AB (8640 reports), followed by co-trimoxazole (2278) and ceftriaxone (2162). The analysis by system organ class shows difference among AB classes, in particular regarding cutaneous (penicillins and macrolides), haematologic (sulfamides), musculo-skeletal and psychiatric (fluoroquinolones) effects.
Conclusion
This descriptive analysis of an important number of case reports give an overview of adverse effects of ABs in real life and must be weighted with utilization data.
Antibiotics (ABs) are widely use drugs. However, frequency and pattern of use of the different ABs may change with time. This could induce changes in the frequency and nature of the reported adverse reaction associated to the use of the ABs different classes. In this context, this study aimed at analysing the reports French spontaneous reporting of suspected adverse drug reactions (ADRs) in order to provide updated information concerning the safety profile of systemic antibiotics (ABs).
Methods
Data were retrieved from the French National Pharmacovigilance database from January 2000 to August 2010. Drugs were coded using the Anatomical Therapeutic Chemical (ATC) classification. The ABs were selected according to the ATC code: J01. The ADRs were coded with MedDRA (Medical Dictionary for Regulatory Activities). Seriousness was coded according to the international definition (ICH)
Results
During the studied period, 31,858 cases (51.4% serious) were reported with ABs, which represent 14.4% of the total number of ADRs reports. No difference in age, gender and seriousness were found between ABs and other drugs. Penicillins were the first class of antibiotics in terms of number of reports per year (report/year: 1360), followed by quinolones (881) and cephalosporins (813). Amoxicillin (alone or in association with clavulanic acid) was the most frequently involved AB (8640 reports), followed by co-trimoxazole (2278) and ceftriaxone (2162). The analysis by system organ class shows difference among AB classes, in particular regarding cutaneous (penicillins and macrolides), haematologic (sulfamides), musculo-skeletal and psychiatric (fluoroquinolones) effects.
Conclusion
This descriptive analysis of an important number of case reports give an overview of adverse effects of ABs in real life and must be weighted with utilization data.