Risk of Acute Liver Injury Associated With the Combination of Amoxicillin and Clavulanic Acid

Rodrı́guez, Luis A. Garcı́a; Stricker, Bruno H.; Zimmerman, Hyman J.

doi:10.1001/archinte.1996.00440110099013

Cited by 91 publications

(51 citation statements)

References 21 publications

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“…The incidence of DILI is much higher with the amoxicillinclavulanic acid combination (1.7 per 10 000 prescriptions) than with amoxicillin alone (0.3 per 10 000 prescriptions). 69,70 Similarly, rechallenge with amoxicillin-clavulanate is followed more often by recurrence than with amoxicillin alone. 71 Liver injury due to amoxicillin-clavulanate is idiosyncratic; risk increases with age, multiple prescriptions, and longer duration of treatment.…”

Section: Some Select Agents That Cause Dilimentioning

confidence: 99%

Drug-Induced Liver Injury

Fisher¹,

Vuppalanchi²,

Saxena

2015

Archives of Pathology &Amp; Laboratory Medicine

161

116

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Context Drug-induced liver injury (DILI) represents a diverse set of responses following exposure to any manufactured or naturally occurring chemical compound. Drug-induced liver injury is of major concern owing to the ever increasing number of compounds introduced into the market for treatment of various diseases as well as the increasing popularity of herbals, which lend themselves to self-medication but are not rigorously regulated. Objective To provide an overview of the prevalence, classification, and diagnosis of DILI with emphasis on pathogenesis and the role of a liver biopsy. To focus on the most common, emerging, and herbal agents that cause DILI with emphasis on the histologic pattern of injury observed. Data Sources A review of the literature was drawn from the PubMed (US National Library of Medicine) repository, textbooks, and online databases. All figures were taken from cases seen at our tertiary referral center, which is 1 of 12 participating sites in the National Institutes of Health–funded Drug-Induced Liver Injury Network. Conclusions Drug-induced liver injury due to prescription, over-the-counter, and herbal products is a major cause of liver disease in the United States and around the world. Diagnosis of DILI is challenging because there is no single clinical, laboratory, or histologic feature specific to DILI. Accurate diagnosis requires establishing a causal relationship with the suspected agent and excluding competing causes of liver injury. The liver biopsy is an essential component in the management of DILI by offering clues to the underlying pathogenesis, providing prognostic information, and guiding therapy.

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Section: Some Select Agents That Cause Dilimentioning

confidence: 99%

Drug-Induced Liver Injury

Fisher¹,

Vuppalanchi²,

Saxena

2015

Archives of Pathology &Amp; Laboratory Medicine

161

116

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“…skin rash, hypereosinophilia, anti-tissue antibodies) suggests an immune-allergic mechanism [22,23]. The reaction could be due also to an idiosyncratic response to the drug [12]. Moreover, currently available evidence suggests a genetic susceptibility to coamoxiclav induced liver injury in patients with specific HLA haplotype [24,25].…”

Section: Discussionmentioning

confidence: 99%

“…However, a limited number of studies are available in scientific literature in which a direct comparison between amoxicillin and co-amoxiclav was made. Rodríguez et al [12], conducted a retrospective cohort study in the United Kingdom in order to estimate the risk of acute liver injury associated with the combination of amoxicillin and clavulanic acid and to compare it with the risk related to amoxicillin alone. Salvo et al [13] analyzed the Italian database of spontaneous reporting of suspected adverse drug reactions (ADRs) in order to compare the safety profile of these two drugs.…”

Section: Introductionmentioning

confidence: 99%

Liver Injury due to Amoxicillin vs. Amoxicillin/Clavulanate: A Subgroup Analysis of a Drug-Induced Liver Injury Case-Control Study in Italy

Donati¹,

Motola²,

Leone³

et al. 2017

J Hepatol Gastroint Dis

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Objective: Several studies showed that amoxicillin plus clavulanic acid (co-amoxiclav) is one of the most common agents associated to serious Drug Induced Liver Injury (DILI). We estimated the risk of acute serious DILI associated with amoxicillin alone compared with co-amoxiclav, through a multicenter case-control study carried out in nine Italian hospitals from October 2010 to January 2014. Methods:Cases were adults, with a diagnosis of acute liver injury. Controls presented acute clinical disorders, not related to chronic conditions and not involving the liver. Adjusted Odds Ratio (ORs) with 95% CI were calculated initially with a bivariate and then multivariate analysis. Results:We analysed 179 cases matched to 1770 controls. Seven cases were exposed to amoxicillin (adjusted OR 1.69, 95% CI 0.72-3.98) and 22 cases to co-amoxiclav (adjusted OR 3.00, 95% CI 1.76-5.40). Conclusions:Co-amoxiclav almost doubled the risk of serious acute liver injury compared to amoxicillin alone. The incidence of co-amoxiclav induced DILI is very low but the widespread use of this drug by the general population makes the risk clinically relevant. The often inappropriate prescription of antimicrobial agents, and in particular of co-amoxiclav, could expose a given patient to a life-threatening risk compared to a negligible clinical benefit.

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“…DILI induced by clavulanic acid compounds typically is manifested by reversible jaundice, but severe cases requiring liver transplant or resulting in fatal outcomes have been reported. 30,[83][84][85] Penicillinase-resistant penicillins are also associated with cholestatic forms of DILI. [86][87][88][89] Macrolides are generally associated with reversible cholestatic liver injury.…”

Section: Other Antibioticsmentioning

confidence: 99%

Drug-Induced Liver Injury

Hamilton

Collins‐Yoder

Collins

2016

AACN Advanced Critical Care

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Drug-induced liver injury (DILI) is common and nearly all classes of medications can cause liver disease. Most cases of DILI are benign, and improve after drug withdrawal. It is important to recognize and remove the offending agent as quickly as possible to prevent the progression to chronic liver disease and/or acute liver failure. There are no definite risk factors for DILI, but preexisting liver disease and genetic susceptibility may predispose certain individuals. Although most patients have clinical symptoms that are identical to other liver diseases, some patients may present with symptoms of systemic hypersensitivity. Treatment of drug and herbal-induced liver injury consists of rapid drug discontinuation and supportive care targeted to alleviate unwanted symptoms. KeywordsDrug-induced liver injury (DILI); drug-induced hepatitis; drug-induced cholestasis; acetaminophen; vanishing bile duct syndrome; herbal toxicity Adverse drug reactions are an important cause of liver injury that may require discontinuation of the offending agent, hospitalization, or even liver transplantation. 1 Indeed, drug-induced hepatotoxicity is the most frequent cause of acute liver failure in US. 2 Because the liver is responsible for concentrating and metabolizing a majority of medications, it is a prime target for medication-induced damage. Among hepatotoxic drugs, acetaminophen (paracetamol) is the most often studied. However, a broad range of different pharmacological agents can induce liver damage, including anesthetics, anticancer drugs, antibiotics, antituberculosis agents, antiretrovirals, and cardiac medications. In addition, a plethora of traditional medical therapies and herbal remedies may also be hepatotoxic.Depending on the duration of injury and the histological location of damage, drug-induced liver injury (DILI) is categorized as acute or chronic, and either as hepatitis, cholestatic, or a mixed pattern of injury. The hepatitis pattern is characterized by hepatocyte necrosis and is associated with a poor prognosis. There are three types of acute cholestatic drug-induced injury: bland cholestasis is the result of abnormal biliary secretion, and is not accompanied by significant hepatocellular damage; cholestatic hepatitis (mixed type) refers to cholestasis with concomitant hepatic parenchymal damage; and the third form of acute cholestasis is

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Risk of Acute Liver Injury Associated With the Combination of Amoxicillin and Clavulanic Acid

Cited by 91 publications

References 21 publications

Drug-Induced Liver Injury

Drug-Induced Liver Injury

Liver Injury due to Amoxicillin vs. Amoxicillin/Clavulanate: A Subgroup Analysis of a Drug-Induced Liver Injury Case-Control Study in Italy

Drug-Induced Liver Injury

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