Adverse drug reactions related to amoxicillin alone and in association with clavulanic acid: data from spontaneous reporting in Italy

Salvo, Francesco; Polimeni, Giovanni; Moretti, Ugo; Conforti, Anita; Leone, Roberto; Leoni, Olivia; Motola, Domenico; Dusi, Giulia; Caputi, Achille P.

doi:10.1093/jac/dkm111

Cited by 101 publications

(79 citation statements)

References 45 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…humans (Gresser 2001;Salvo et al 2007). However, according to the JECFA (2012) report, 26-week study of amoxicillin toxicity on small rodents did not reveal any changes that may suggest hepatotoxicity or nephrotoxicity.…”

Section: Discussionmentioning

confidence: 99%

The Role of Chronic Exposure to Amoxicillin/Clavulanic Acid on the Developmental Enamel Defects in Mice

et al. 2015

View full text Add to dashboard Cite

Amoxicillin used in early childhood may be associated with enamel hypomineralization. Our aim was to assess disturbances of amelogenesis in mice lower incisors induced by chronic administration of amoxicillin/clavulanic acid (AMC). Twenty-eight C57BL/6 male mice, of similar age, randomly divided into a control and 3 treatment groups (n ¼ 7) received subcutaneous injection, once per day, for 60 days: 50, 100, and 150 mg/kg BW of AMC. Scanning electron microscopy/energy dispersive X-ray spectroscopy analysis in AMC treatment groups showed higher content in F and a decrease in P and Ca. Morphology changes ranged from scratched patterns, and small isolated pits-like enamel loss, to generalized demineralized enamel surface, giving a rough, foamy, scaly, or even cracked eggshell appearance to the affected areas. Histological analysis showed disturbances of maturation ameloblasts, which were less organized, with increased amounts of clear vacuoles in the cytoplasm and slightly more elongated and less condensed nucleus. Additionally, they were often detached from the enamel matrix. Transitional ameloblasts formed underlying the cysts of varied sizes. In conclusion, AMC dose-dependently affect ameloblast functions especially in the maturation phase, causing hypomineralized enamel formation with quantitative and/or qualitative defects.

show abstract

Section: Discussionmentioning

confidence: 99%

The Role of Chronic Exposure to Amoxicillin/Clavulanic Acid on the Developmental Enamel Defects in Mice

et al. 2015

View full text Add to dashboard Cite

show abstract

“…For example, amoxicillin-clavulanate usually results in a cholestatic injury but less frequently has also been associated with ALF. 17,18 Another way to classify idiosyncratic DILI is as immunemediated (allergic) or non-immune mediated (nonallergic). 19 If immune-mediated, the latency is shorter (1-6 weeks) compared with non-immune mediated reactions (1 month to 1 year).…”

Section: Epidemiologymentioning

confidence: 99%

Drug-induced liver injury

2016

View full text Add to dashboard Cite

Drug-induced liver injury (DILI) remains the most common cause of acute liver failure (ALF) in the western world. Excluding paracetamol overdose, nearly all DILI encountered in the clinical setting is idiosyncratic in nature because affected individuals represent only a small proportion of those treated with such drugs. In many cases, the mechanism for idiosyncrasy is immune-mediation and is often identifi ed by genetic risk determined by human leukocyte antigen variants. In the absence of diagnostic tests and/or biomarkers, the diagnosis of DILI requires a high index of suspicion after diligently excluding other causes of abnormal liver tests. Antibiotics are the class of drugs most frequently associated with idiosyncratic DILI, although recent studies indicate that herbal and dietary supplements are an increasingly recognised cause. It is imperative that upon development of DILI the culprit drug be discontinued, especially in the presence of elevated transaminases (aspartate aminotransferase/alanine aminotransferase ratio ≥5 times the upper limit of normal) and/or jaundice. Risk factors for the development ALF include hepatocellular DILI and female gender, the treatment being supportive with some benefi t of N-acetylcysteine in the early stages. In view of the poor transplant-free survival in idiosyncratic DILI, early consideration for liver transplant is mandatory. KEYWORDS : Autoimmune hepatitis , cholestasis , drug-induced acute liver failure , herbal and dietary supplements , hepatocellular DILI , hepatotoxicity IntroductionAt a regulatory level, drug-induced liver injury (DILI) is the commonest reason for withdrawing drugs from the market and/or issuing warnings and modification of use.1 DILI is classified as either predictable or unpredictable (idiosyncratic). 2The former tends to be dose-related, has a short latency (days), is due to direct toxicity of the drug or its metabolite, and is ABSTRACT Drug-induced liver injuryreproducible in animal models (eg paracetamol overdose). 3The vast majority of DILI, however, is idiosyncratic or unpredictable -it is unexpected based on the pharmacological actions of the drug and in most cases routine animal toxicology fails to identify the risk of subsequent clinical toxicity. 4 This review shall largely focus on idiosyncratic DILI .

show abstract

“…Therefore, drug utilization studies are important as they invariably bridge the gap between public health, rational pharmacotherapy, pharmaco-vigilance and pharmaco-economics [13]. The indiscriminate use of broad-spectrum antibiotics is much emphasized in various studies [14][15][16]. The studies dealing with prescription audits are invariably form a subset of the antimicrobial stewardship programme that is designed to overcome the problem of antibiotic resistance.…”

Section: Discussionmentioning

confidence: 99%

Restricted Parenteral Antibiotics Usage Policy in a Tertiary Care Teaching Hospital in India

Tiwari

Ghongane

Daswani

et al. 2017

JCDR

View full text Add to dashboard Cite

Adverse drug reactions related to amoxicillin alone and in association with clavulanic acid: data from spontaneous reporting in Italy

Cited by 101 publications

References 45 publications

The Role of Chronic Exposure to Amoxicillin/Clavulanic Acid on the Developmental Enamel Defects in Mice

The Role of Chronic Exposure to Amoxicillin/Clavulanic Acid on the Developmental Enamel Defects in Mice

Drug-induced liver injury

Restricted Parenteral Antibiotics Usage Policy in a Tertiary Care Teaching Hospital in India

Contact Info

Product

Resources

About