Can causality assessment fulfill the new European definition of adverse drug reaction? A review of methods used in spontaneous reporting

Mascolo, Annamaria; Scavone, Cristina; Sessa, Maurizio; Mauro, Gabriella di; Cimmaruta, Daniela; Orlando, Valentina; Rossi, Francesco; Sportiello, Liberata; Capuano, Annalisa

doi:10.1016/j.phrs.2017.07.005

Cited by 45 publications

(33 citation statements)

References 41 publications

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“…One must be aware upon reading this review, there is no necessarily causation between documented AEs and pharmacological treatment [11]. As hepatitis B infection itself may lead to extrahepatic organ involvement [12], it might be difficult to determine whether extrahepatic manifestations/symptoms are treatment-related or a disease manifestation.…”

Section: Discussionmentioning

confidence: 99%

Adverse events of nucleos(t)ide analogues for chronic hepatitis B: a systematic review

et al. 2020

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Nucleos(t)ide analogues (NAs) are the main drug category used in chronic hepatitis B (CHB) treatment. Despite the fact that NAs have a favourable safety profile, undesired adverse events (AEs) may occur during the treatment of CHB. Given the eminent number of patients currently receiving NAs, even a small risk of any of these toxicities can represent a major medical issue. The main objective of this review was to analyse information available on AEs associated with the use of NAs in published studies. We choose the following MesH terms for this systematic review: chronic hepatitis B, side effects and treatment. All articles published from 1 January 1990 up to 19 February 2018 in MEDLINE of PubMed, EMBASE, the Cochrane Library and LILACS databases were searched. A total of 120 articles were selected for analysis, comprising 6419 patients treated with lamivudine (LAM), 5947 with entecavir (ETV), 3566 with tenofovir disoproxil fumarate (TDF), 3096 with telbivudine (LdT), 1178 with adefovir dipivoxil (ADV) and 876 with tenofovir alafenamide (TAF). The most common AEs in all NAs assessed were abdominal pain/discomfort, nasopharyngitis/upper respiratory tract infections, fatigue, and headache. TAF displays the highest density of AEs per patient treated among NAs (1.14 AE/treated patient). In conclusion, treatment of CHB with NAs is safe, with a low incidence of AEs. Despite the general understanding TAF being safer than TDF, the number of patients treated with TAF still is too small in comparison to other NAs to consolidate an accurate safety profile. PROSPERO Registration No. CRD42018086471

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Section: Discussionmentioning

confidence: 99%

Adverse events of nucleos(t)ide analogues for chronic hepatitis B: a systematic review

et al. 2020

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“…Only few haematological side effects (leucopenia, thrombocytopenia, agranulocytosis, aplastic anaemia, eosinophilia, haematolytic anaemia) are described with naproxen use (frequency <0.01%) . In our case, in order to evaluate the causality for each adverse reaction‐drug pair, we used the French method causality assessment, recommended in overdose cases . The intrinsic imputability score was the highest for the pair naproxen‐coagulopathy; indeed, the blood concentration was at a toxic level knowing that hypoprothrombinaemia is a symptom of naproxen overdose as described in the overdose section of summary of product characteristics (SmPC)…”

Section: Discussionmentioning

confidence: 99%

“…Concerning the evaluation of causality for each adverse reaction‐drug pair in overdose cases, Mascolo et al concluded that French method causality assessment can be performed unlike Naranjo method . The imputability is based on considering chronological, semiological and publication criteria.…”

Section: Methodsmentioning

confidence: 99%

Severe poisoning with naproxen causing coagulopathy

Lelièvre

Drouillard²,

Thill³

et al. 2019

Basic Clin Pharma Tox

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Non-steroidal anti-inflammatory drugs (NSAIDs) are well known for their most frequent side effects (digestive, renal and metabolic disorders) but are lesser known for other effects, such as coagulation disturbances. In this issue, we report the case of a 58-year-old woman who ingested 26 g of naproxen in a suicidal attempt and developed cardiovascular shock, hypocoagulability and thrombopenia. Her outcome was positive (extubation 3 days after admission [D3], correction of haemostatic disruptions on D5 and of thrombopenia on D6). Naproxen plasma concentration was at a toxic concentration of 1320 mg/L at 6 hours after drug ingestion. Only few cases of hypocoagulopathy are reported with the NSAIDs, and this is the first case that can be attributed to naproxen. A possible explanation of this phenomenon following naproxen ingestion is an inhibition of thromboxane A2, usually attributed to NSAIDs, combined with an inhibition of activation of downstream the cascade. K E Y W O R D S hypocoagulopathy, naproxen, thrombopenia, thromboxane A2 How to cite this article: Lelièvre B, Drouillard I, Thill C, et al. Severe poisoning with naproxen causing coagulopathy.

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“…The methodological quality of case reports and cases series was assessed using the tool proposed by Murad et al (9) modified to adapt it to the analysis of toxicological exposures associated with PRES. The selected items were based on scores used for causality assessment in drug overdose (10,11). This new tool converges into 10 items that can be categorized into six domains: selection, ascertainment, diagnosis, causality, follow-up, and reporting (Supplementary Table 1).…”

Section: Methodological Quality Assessmentmentioning

confidence: 99%

Posterior Reversible Encephalopathy Syndrome in Clinical Toxicology: A Systematic Review of Published Case Reports

et al. 2020

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Background: Posterior reversible encephalopathy syndrome (PRES) is a rare clinical and radiological entity characterized by a typical brain edema. Although several case reports have described PRES in a context of poisoning, to our knowledge, a comprehensive assessment has not been performed. The aim of this systematic review was to raise awareness on poisoning-specific PRES features and to encourage consistent and detailed reporting of substance abuse-and drug overdose-associated PRES. Methods: Medline/PubMed, Web of Science, and PsycINFO were screened through May 31, 2019, to systematically identify case reports and case series describing PRES associated with poisoning (i.e., alcohol, drugs, illicit drugs, natural toxins, chemical substances) in accidental context, intentional overdose, and substance abuse. The methodological quality of eligible case reports/series was assessed. Patients and exposure characteristics were recorded; relevant toxicological, radiological, and clinical data were extracted. Results: Forty-one case reports and one case series reporting 42 unique cases were included. The median time to PRES onset from the start of exposure was 3 days (IQR 2-10). Acute high blood pressure, visual disturbance, and seizure were reported in 70, 55, and 50% of patients, respectively. The initial clinical presentation was alertness disorders in 64% of patients. Nine patients (21%) required mechanical ventilation. One-third of patients had at least one risk factor for PRES such as chronic hypertension (17%) or acute/chronic kidney failure (24%). The main imaging pattern (67%) was the combination of classical parieto-occipital edema with another anatomical region (e.g., frontal, basal ganglia, posterior fossa involvement). Vasogenic edema was found in 86% of patients. Intracranial hemorrhage occurred in 14% of patients. Both brain infarction and reversible cerebral vasoconstriction syndrome were diagnosed in 5% of patients. Three patients (12%, 3/25) had non-reversible lesions on follow-up magnetic resonance Largeau et al. PRES in Clinical Toxicology imaging. The median time required to hospital discharge was 14 days (IQR 7-18). Mortality and neurological recurrence rate were null. Conclusions: Comorbidities such as chronic hypertension and kidney failure were less frequent than in patients with other PRES etiologies. Imaging analysis did not highlight a specific pattern for poisoning-induced PRES. Although less described, PRES in the context of poisoning, which shares most of the clinical and radiological characteristics of other etiologies, is not to be ignored.

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Can causality assessment fulfill the new European definition of adverse drug reaction? A review of methods used in spontaneous reporting

Cited by 45 publications

References 41 publications

Adverse events of nucleos(t)ide analogues for chronic hepatitis B: a systematic review

Adverse events of nucleos(t)ide analogues for chronic hepatitis B: a systematic review

Severe poisoning with naproxen causing coagulopathy

Posterior Reversible Encephalopathy Syndrome in Clinical Toxicology: A Systematic Review of Published Case Reports

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