Hepatic injury associated with the use of nitrofurans: A clinicopathological study of 52 reported cases

Stricker, Bruno H. Ch.; Blok, A. P. R.; Claas, Frans H.J.; Parys, G.E. Van; Desmet, Valeer

doi:10.1002/hep.1840080327

Cited by 144 publications

(103 citation statements)

References 29 publications

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“…A few drugs, such as isoniazid flucloxacillin, halothane, amoxicillin/clavulanate, and nitrofurantoin, were reported to increase the risk of iDILI in older individuals 3, 4, 5, 6, 7. In female patients, there are some trends in the patterns of injury, with hepatocellular as well as autoimmune‐like injury being common 8.…”

Section: Diagnosis Of Idilimentioning

confidence: 99%

Idiosyncratic drug‐induced liver injury: A short review

Yamashita

Imai

Mima

et al. 2017

Hepatology Communications

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Idiosyncratic drug‐induced liver injury (iDILI) is a rare adverse drug reaction that occasionally leads to acute liver failure or even death. An aging population that uses more drugs, a constant influx of newly developed drugs, and a growing risk from herbal and dietary supplements of uncertain quality can lead to an increase in iDILI. Antimicrobials, central nervous system agents, and herbal and dietary supplements are the most common causes of iDILI in developed countries. iDILI is still a diagnosis of exclusion, and thus careful history taking and thorough work‐ups for competing etiologies, such as acute viral hepatitis, autoimmune hepatitis, and others, are essential. The pathogenesis of iDILI is not clear and includes a mix of host reactions, drug metabolites, and environmental factors. Immediate cessation of the suspected offending drug is key to preventing or minimizing progressive damage. No definitive therapies for iDILI are available, and the treatments remain largely supportive. (Hepatology Communications 2017;1:494–500)

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Section: Diagnosis Of Idilimentioning

confidence: 99%

Idiosyncratic drug‐induced liver injury: A short review

Yamashita

Imai

Mima

et al. 2017

Hepatology Communications

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“…[92][93][94][95] Macrodantin is well recognized to induce both acute and chronic liver disease, and may be indistinguishable from autoimmune hepatitis. 96,97 …”

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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“…No increase in adverse reactions in children could be observed during this 27-year period. Stricker et al (1988) reviewed hepatic injuries associated with the use of nitrofurantoin and nifurtoinol (hydroxymethyl-nitrofurantoin) that had been reported since 1963 to the Netherlands Centre for Monitoring of Adverse Reactions to Drugs. In this period of 25 years, 50 cases were associated with nitrofurantoin and, in 38 cases, a causal relationship was considered to be likely.…”

Section: Observations In Humans 841 Human Pharmacological and Toximentioning

confidence: 99%

Scientific Opinion on nitrofurans and their metabolites in food

Panel¹

2015

EFS2

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Nitrofurans are antimicrobial agents not authorised for use in food-producing animals in the European Union. Nitrofurans are rapidly metabolised, occurring in animal tissues as protein-bound metabolites. The European Commission requested EFSA to provide a scientific opinion on the risks to human health related to the presence of nitrofurans in food and whether a reference point for action (RPA) of 1.0 µg/kg for the marker metabolites is adequate to protect public health. Data on occurrence of nitrofuran marker metabolites in food were extracted from the national residue monitoring plan results and from the Rapid Alert System for Food and Feed (RASFF). The CONTAM Panel concluded that these data were too limited to carry out a reliable human dietary exposure assessment. Instead, human dietary exposure was calculated for a scenario in which a single nitrofuran marker metabolite is present at 1.0 µg/kg in foods of animal origin, excluding milk and dairy products. The mean chronic dietary exposure for this worst-case scenario would range from 3.3 to 8.0 and 1.9 to 4.3 ng/kg b.w. per day for toddlers and adults, respectively. Nitrofurans and their marker metabolites, generally, are genotoxic and carcinogenic and, also, have non-neoplastic effects in animals. Margins of exposure (MOEs) were calculated at 2.0 × 10 5 or greater for carcinogenicity and at 2.5 × 10 3 or greater for non-neoplastic effects. The CONTAM Panel concluded that it is unlikely that exposure to food contaminated with nitrofuran marker metabolites at or below 1.0 µg/kg is a health concern. A scenario in which foods are considered to be contaminated with semicarbazide, from use of carrageenan as a food additive, at 1 µg/kg was used to assess whether it is appropriate to apply the RPA to foods of non-animal origin; MOEs of greater than 10 4 calculated for nonneoplastic effects do not indicate a health concern.© European Food Safety Authority, 2015 However, the opinion also identified certain categories of non-allowed pharmacologically active substances that are considered to be outside the scope of the procedure, including substances that are high potency carcinogens, such as nitrofurans. As nitrofurans are excluded from that opinion, and taking into account that the presence of SEM in food may be from sources other than use of nitrofurazone, the European Commission (EC) requested the European Food Safety Authority (EFSA) for a scientific opinion on the risks to human health related to the presence of nitrofurans and their metabolites in food. The opinion should include (a) an evaluation of the toxicity of nitrofurans and their metabolites for humans, considering all relevant toxicological endpoints and identification of the toxicological relevance of nitrofurans and their metabolites present in food, and (b) an exposure assessment of the EU population to nitrofurans and their metabolites from food, including the consumption patterns of specific (vulnerable) groups of the population. In addition, the opinion should assess the appropriateness of...

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Hepatic injury associated with the use of nitrofurans: A clinicopathological study of 52 reported cases

Cited by 144 publications

References 29 publications

Idiosyncratic drug‐induced liver injury: A short review

Idiosyncratic drug‐induced liver injury: A short review

Drug-Induced Liver Injury

Scientific Opinion on nitrofurans and their metabolites in food

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