A study of agreement between the Naranjo algorithm and WHO-UMC criteria for causality assessment of adverse drug reactions

Belhekar, Mahesh N; Taur, Santosh; Munshi, Renuka

doi:10.4103/0253-7613.125192

Cited by 89 publications

(47 citation statements)

References 15 publications

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“…Causality assessment aid regulatory authorities in evaluating ADRs and risk-benefit decisions about medicines. 10,11 Causality assessment algorithms are organised frameworks that help in objective decision making on causality. 12 Causality assessment should be recommended and performed widely once ADR monitoring is intensified in all health care institute by educating and motivating healthcare providers to report ADRs.…”

Section: Discussionmentioning

confidence: 99%

Causality Assessment of Adverse Drug Reaction Using Naranjo Probability Scale: A Retrospective Study

Bajracharya

Ghimire

Khadka

2020

Med. J. Shree Birendra Hosp.

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Introduction: Globally, Adverse Drug Reaction (ADR) has been listed as the sixth leading causes of death. Recognition of ADR and establishment of relationship of drug with the symptom is the first step to the management of the problem. In this study, Naranjo algorithm has been used which is one of the most accepted tools for the assessment of causality of ADR with the suspected drug. Methods: A retrospective descriptive study was done which included 35 reported cases of ADRs in Drug Information Unit (DIU) in tertiary care teaching institute of Nepal from Dec 2015 to Oct 2016. Based on the information in the reported ADRs forms, categorisation was done using Naranjo’s ADR Probability scale. The data was analysed using SPSS version 16.0 and descriptive statistics was used. Results: It was seen that ADRs were more common in male (n=20) as compared to female (n=15). Amongst male, ADRs were more common in age group 50-75 years (n=8). ADRs were most commonly seen with antimicrobial agents (40%) followed by Non-Steroidal Anti-inflammatory Drugs (NSAIDs) (20%) and immunosuppressants (20%). Within the antimicrobial agents, anti-tubercular drugs (20%) contributed the most in ADRs and hepatotoxicity was the most common ADR seen. Majority of ADRs were categorised under possible (n=29) followed by probable (n=6). Conclusions: Naranjo algorithm could be a useful tool for causality assessment of ADR which can help physicians to guide the therapy.

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Section: Discussionmentioning

confidence: 99%

Causality Assessment of Adverse Drug Reaction Using Naranjo Probability Scale: A Retrospective Study

Bajracharya

Ghimire

Khadka

2020

Med. J. Shree Birendra Hosp.

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“…II), were similar for the both D-ADRs and CM-ADRs. However, a previous study reported poor agreement between the Naranjo algorithm and WHO-UMC criteria [ 32 ]. In another study, “probable” or “certain” ADRs were scored more often when using the Korean algorithm (ver.…”

Section: Discussionmentioning

confidence: 99%

Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions

et al. 2015

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ObjectiveWe analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions.MethodsAdverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary’s teaching hospital, Daejeon, Korea) from 2010–2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton’s preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed.ResultsOf 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p < 0.001), and more likely to be type A reactions (73.5% vs. 18.8%, p < 0.001). Females were over-represented among drug-induced adverse reactions (68.1%, p < 0.001) but not among contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization–Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p < 0.001).ConclusionsWe found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse reactions. The World Health Organization–Uppsala Monitoring Centre and Naranjo algorithm causality evaluation afforded similar results.

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“…Many causality scoring systems have been used for evaluation of adverse drug reaction. We used Naranjo score and WHO-UMC in our patients and it was “probable” and “certain” ADR according to these categories, respectively [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Carum induced hypothyroidism: an interesting observation and an experiment

2015

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Carum carvi is a widely available herb that has been used as a food additive and as a medication in traditional medicine for many years. Its potential biological effects include analgesic, anti-inflammatory, anti-anxiety and antispasmodic activities. We report a patient with papillary thyroid carcinoma who were under treatment with levothyroxine and experienced an elevated TSH level by ingestion of Carum carvi. TSH level was increased to 60.3 mIU/L with no change in levothyroxine dosage and decreased to normal range after discontinuation of the Carum carvi. Observing this dramatic change in TSH level by carum ingestion, carum carvi capsules was produced and one of the researcher tried the medication on herself with a dose of 40 mg/kg/day. She had a history of hypothyroidism and was taking 100 ugr/day of levothyroxine. TSH was markedly increased 2 weeks after ingestion of Carum carvi and returned to normal range 5 months after discontinuation of it. This case report shows the effect of consumption of Carum carvi in increasing TSH level in hypothyroid patients treating with levothyroxine. The exact mechanism of action of carum carvi remains unknown.

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A study of agreement between the Naranjo algorithm and WHO-UMC criteria for causality assessment of adverse drug reactions

Cited by 89 publications

References 15 publications

Causality Assessment of Adverse Drug Reaction Using Naranjo Probability Scale: A Retrospective Study

Causality Assessment of Adverse Drug Reaction Using Naranjo Probability Scale: A Retrospective Study

Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions

Carum induced hypothyroidism: an interesting observation and an experiment

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