Interaction between paracetamol and lamotrigine: new insights from the FDA Adverse Event Reporting System (FAERS) database

Carnovale, Carla; Mosini, Giulia; Gringeri, Michele; Battini, Vera; Mazhar, Faizan; Pozzi, Marco; Clementi, Emilio; Radice, Sonia

doi:10.1007/s00228-019-02691-4

Cited by 14 publications

(9 citation statements)

References 8 publications

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“…Adverse events are recorded in the FAERS using the Medical Dictionary for Regulatory Activities (MedDRA ® ) preferred terms. The database is largely used to detect novel drug-related safety events, to identify possible mechanisms of adverse events, to explore potential drug-drug interactions ( Carnovale et al, 2019b ; Mazhar et al, 2019 ). Adverse events recorded in the FAERS were downloaded from the Food and Drug Administration (FDA) website ( FDA Adverse Event Reporting System, 2019 (FAERS) Quarterly Data Extract Files).…”

Section: Methodsmentioning

confidence: 99%

“…Despite the intrinsic limitations, we used the spontaneous reporting systems FDA Adverse Event Reporting System (FAERS), as it still represent a valuable source of real-world data about the safety/efficacy profile of specific drugs; it also allows to compare therapeutic options, gain relevant insights on potential mechanisms of adverse drug reactions (ADRs ) ( Carnovale et al, 2018 , 2019a , 2019b ; Mazhar et al, 2019 ) , and estimate the time to onset of ADRs ( Mazhar et al, 2021 ), thus contributing to prevent ADRs and improve the pharmacological management of iatrogenic disorders. The results we obtained provide new insights towards improving the diagnosis of antibiotic-induced neutropenia, in the pediatric clinical setting.…”

Section: Introductionmentioning

confidence: 99%

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Antibiotic-Induced Neutropenia in Pediatric Patients: New Insights From Pharmacoepidemiological Analyses and a Systematic Review

et al. 2022

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Aim: to characterize pediatric cases of antibiotic-associated neutropenia through a multidisciplinary approach, focusing on the temporal association between the wide spectrum of treatment options and the occurrence of this relatively uncommon but potentially clinically relevant adverse event.Methods: we carried out a pharmacoepidemiological analysis based on the FDA Adverse Event Reporting System (FAERS) database, a retrospective chart review and a systematic review of the literature, focusing on the time to onset (TTO) of this side effect, in the pediatric clinical setting.Results: A total of 281 antibiotic-related neutropenia events, involving 11 categories of antibiotics, were included in the time to onset analysis. The median TTO ranged from 4 to 60 days after the start of the therapy. A shorter median TTO was found from the retrospective chart review [16 patients: median days (25th-75th percentiles) = 4 (3–5)], compared to 15 (9–18) vs. 10 (6–18) for literature (224 patients) and FAERS (41 cases), respectively. The Anatomical Therapeutic Chemical classes, J01X, J01F, J01E and J04A, and the median TTOs retrieved from more than one source revealed high accordance (p > 0.05), with J01X causing neutropenia in less than a week and J01F/J01E/J04A in more than 10 days. Antibiotics were discontinued in nearly 34% of cases. In FDA Adverse Event Reporting System reports, half of the patients experiencing neutropenia were hospitalized.Conclusion: Whereas antibiotic associated neutropenia is benign in the majority of cases, yet it should not be neglected as, even if rarely, it may put children at higher risk of clinical consequences. Clinicians’ awareness of antibiotic-associated neutropenia and its mode of presentation contributes to the continuous process of monitoring safety of antibiotics.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Antibiotic-Induced Neutropenia in Pediatric Patients: New Insights From Pharmacoepidemiological Analyses and a Systematic Review

et al. 2022

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“…Both, changes in expression and activity of enzymes or competitive inhibition may contribute to the specific interaction between paracetamol and lamotrigine. The clinical relevance was confirmed by a study reporting an enhanced potential for a decrease in lamotrigine exposure along with a detrimental effect on seizure control ( Carnovale et al, 2019 ).…”

Section: Potential Drug Interactions Between Asms and Antipyretic And Anti-inflammatory Drugs Concomitantly Used In Covid-19 Patientsmentioning

confidence: 87%

Management of COVID-19 in patients with seizures: Mechanisms of action of potential COVID-19 drug treatments and consideration for potential drug-drug interactions with anti-seizure medications

et al. 2021

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In regard to the global pandemic of COVID-19, it seems that persons with epilepsy (PWE) are not more vulnerable to get infected by SARS-CoV-2, nor are they more susceptible to a critical course of the disease. However, management of acute seizures in patients with COVID-19 as well as management of PWE and COVID-19 needs to consider potential drug-drug interactions between antiseizure drugs and candidate drugs currently assessed as therapeutic options for COVID-19. Repurposing of several licensed and investigational drugs is discussed for therapeutic management of COVID-19. While for none of these approaches, efficacy and tolerability has been confirmed yet in sufficiently powered and controlled clinical studies, testing is ongoing with multiple clinical trials worldwide. Here, we have summarized the possible mechanisms of action of drugs currently considered as potential therapeutic options for COVID-19 management along with possible and confirmed drug-drug interactions that should be considered for a combination of antiseizure drugs and COVID-19 candidate drugs. Our review suggests that potential drug-drug interactions should be taken into account with drugs such as chloroquine/hydroxychloroquine and lopinavir/ritonavir while remdesivir and tocilizumab may be less prone to clinically relevant interactions with ASMs.

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“…ICSRs provide administrative information (country, type of report, qualification of the reporter), patient demographics (gender, age, weight), adverse events (seriousness of the ADR, date of onset reaction, outcome), information about drug therapy (drug name, drug start and stop dates, time to onset, dose, indication, dechallenge and rechallenge), but the level of completeness of information varies from case to case (Sakaeda et al, 2013). As the number of safety reports sent to the FDA annually is continuously expanding, the database is largely used to detect novel drug-related safety events (Carnovale et al, 2019a;Carnovale et al, 2019b;Mazhar et al, 2019;Pozzi et al, 2019).…”

Section: Us Food and Drug Administration Adverse Event Reporting Systmentioning

confidence: 99%

Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review

et al. 2021

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The published experience with biologics in childbearing age with autoimmune and inflammatory diseases mainly deals with the use of TNFα inhibitors (TNFα-i). Limited data are available for biologics targeting other cytokines or immunocompetent cells, especially for the inflammasome targeted therapy including IL-1 inhibitors and colchicine. We conducted a nested case-control study by using the US Food and Drug Administration Adverse Event Reporting System database aimed at quantifying the association between the use of IL-1 inhibitors/colchicine in pregnant women and the occurrence of maternal/fetal adverse effects. The reporting odds ratio was used as a measure of disproportional reporting. From the total cohort (40,033 pregnant women), we retrieved 7,620 reports related to neonatal AEs, 2,889 to fetal disorders, 8,364 to abortion, 8,787 to congenital disorders, and 7,937 to labor/delivery complications. Inflammasome-targeted drugs did not present any disproportionate reporting for all these clusters of AEs. TNFα-i confirmed their safety during pregnancy with aROR < 1 for all clusters of AEs except for labor complications. Finally, we performed a systematic review of the current literature. Data from the eligible studies (12 observational studies and 6 case reports; yielding a total of 2,075 patients) were reassuring. We found no major safety issues on malformations risk of inflammasome targeted therapies in pregnancy. However, due to limited data, the routine use of these agents should be considered in pregnancy only if risk benefit assessment justifies the potential risk to the fetus.

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Interaction between paracetamol and lamotrigine: new insights from the FDA Adverse Event Reporting System (FAERS) database

Cited by 14 publications

References 8 publications

Antibiotic-Induced Neutropenia in Pediatric Patients: New Insights From Pharmacoepidemiological Analyses and a Systematic Review

Antibiotic-Induced Neutropenia in Pediatric Patients: New Insights From Pharmacoepidemiological Analyses and a Systematic Review

Management of COVID-19 in patients with seizures: Mechanisms of action of potential COVID-19 drug treatments and consideration for potential drug-drug interactions with anti-seizure medications

Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review

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