J Korean Med Sci.  2012 Mar;27(3):268-273. 10.3346/jkms.2012.27.3.268.

Spontaneously Reported Hepatic Adverse Drug Events in Korea: Multicenter Study

• Kwon H
• Lee SH
• Kim SE
• Lee JH
• Jee YK
• Kang HR
• Park BJ
• Park JW
• Hong CS

• KMID: 1792997
• DOI: http://doi.org/10.3346/jkms.2012.27.3.268

Abstract

Hepatic adverse drug reactions (ADRs) to certain drugs may differ within each country, reflecting different patterns of prescription, socioeconomic status, and culture. The purpose of this study was to assess the suspected cause of hepatic ADRs using the spontaneously reported pharmacovigilance data from Korea. A total of 9,360 spontaneously reported adverse drug events (ADEs) from nine Pharmacovigilance Centers were analyzed. Risk of hepatic ADEs was assessed by calculating the reporting odds ratio (ROR). Of the 9,360 cases, 567 hepatic ADEs were reported. The most frequently prescribed drug classes inducing hepatic ADEs were anti-tuberculotics, cephalosporins, valproic acids, penicillins, quinolones, non-steroidal anti-inflammatory drugs (NSAIDs), anti-viral agents, and statins. ROR values were especially high in anti-tuberculosis drugs, systemic antifungal drugs for systemic use, anti-epileptics, propylthiouracil, and herbal medicines. Underlying diseases such as tuberculosis (6.9% vs 0.9%), pneumonia (4.9% vs 1.7%), intracranial injury including skull fracture (4.5% vs 0.9%), HIV (3.4% vs 0.4%), subarachnoid hemorrhage (2.8% vs 0.5%), and osteoporosis (2.4% vs 1.4%) were significantly more common in hepatic ADE group. In conclusion, anti-infective drugs, anti-epileptics, NSAIDs and statins are the most common suspects of the spontaneously reported hepatic ADEs, in Korea. Careful monitoring for such reactions is needed for the prescription of these drugs.

Keyword

Drug-Induced Hepatitis; Etiology; Spontaneous Pharmacovigilance

MeSH Terms

Adult
*Adverse Drug Reaction Reporting Systems/statistics & numerical data
Aged
Anti-Infective Agents/adverse effects
Anti-Inflammatory Agents, Non-Steroidal/adverse effects
Anticonvulsants/adverse effects
Drug Monitoring
Drug-Induced Liver Injury/*epidemiology/*etiology
Female
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects
Male
Middle Aged
Odds Ratio
Pharmacovigilance
Republic of Korea/epidemiology
Risk Factors

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