ArticleBMC clinical pharmacology2008
Individual case safety reports in children in commonly used drug groups - signal detection.
Article in BMC clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- Pharmacovigilance in children: detecting adverse drug reactions in routine electronic healthcare records. A systematic review.British journal of clinical pharmacology · 2015Pooled it
- Tiotropium add-on therapy is safe and reduces seasonal worsening in paediatric asthma patients.The European respiratory journal · 2019Trial
- The Impact of Montelukast Duration on the Risk of Neuropsychiatric Disorders in Children with Asthma: A Population-Based Cohort Study.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Adverse drug reactions to antiretroviral therapy: Results from spontaneous reporting system in Nigeria.Perspectives in clinical research · 2013Article
- A study of adverse drug reactions in pediatric patients.Journal of pharmacology & pharmacotherapeutics · 2011Article
- Association between leukotriene-modifying agents and suicide: what is the evidence?Drug safety · 2011Review
- Montelukast and emotional well-being as a marker for depression: results from 3 randomized, double-masked clinical trials.The Journal of allergy and clinical immunology · 2008Review
- Pediatric pharmacovigilance in an institute of national importance: Journey has just begun.Indian journal of pharmacologyArticle
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDue to few paediatric drug safety studies, knowledge on risks of drug treatment in children is limited. The knowledge needs to be increased to make proper risk-benefit analyses possible when treating paediatric patients with drugs. The aim of the present study was to investigate drug groups commonly used in children concerning type and frequency of individual case safety reports in children.
methodsNumber and type of individual case safety reports in the 30 groups of drugs (5th level ATC-code) most sold (number of defined daily doses) in outpatient treatment to children (<15 years old) during 2005 were obtained. Descriptive analyses of the adverse drug reactions reported in children were performed.
resultsThe number of individual case safety reports per million defined daily doses in children varied in the groups of drug between 0 and 24. The largest number was found in the drug group R03DC, the leukotriene receptor antagonist montelukast; the majority of the children being <5 years old and experiencing psychiatric adverse drug reactions.
conclusionThe number of individual case safety reports per million defined daily doses varies in different groups of drugs. A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.