Use of amoxicillin and amoxicillin-clavulanic acid and hospitalization for acute liver injury.
Increase of acute liver injury in patients taking amoxicillin-clavulanic acid (co-amoxiclav) as compared to those taking amoxicillin has been suggested. To further investigate the potential hepatotoxicity of the two drugs a historical cohort study was conducted in the Italian region of Friuli-Venezia Giulia. One hundred and eighteen potential cases of acute liver injury were identified through the regional hospital information system and medical records were reviewed for all of them. Overall, 12 cases of acute liver injury were identified: 3 cases occurred in the amoxicillin exposure category, 2 among co-amoxiclav group, and 7 in the non-use category. The adjusted estimate of the rate ratio was 5.7 (CI 95% 1.5-22.1) among users of amoxicillin alone and 6.2 (CI 95% 1.3-29.7) among users of co-amoxiclav.
Maggini
M
M
Laboratorio di Epidemiologia e Biostatistica, Istituto Superiore di Sanità, Rome, Italy.
Raschetti
R
R
Agostinis
L
L
Cattaruzzi
C
C
Troncon
M G
MG
Simon
G
G
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000658:Amoxicillin / Q000009:adverse effects*; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000009:adverse effects*; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology / Q000209:etiology*; D015331:Cohort Studies; D004359:Drug Therapy, Combination / Q000009:adverse effects*; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010406:Penicillins / Q000009:adverse effects*; D012306:Risk
D000900:Anti-Bacterial Agents; D010406:Penicillins; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin