Asthma Morbidity After the Short-Term Use of Ibuprofen in Children

Lesko, Samuel M.; Louik, Carol; Vezina, Richard M.; Mitchell, Allen A.

doi:10.1542/peds.109.2.e20

Cited by 175 publications

(137 citation statements)

References 15 publications

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“…To determine the effects of the medicines on asthma in one study, 72 a subgroup analysis was performed to determine the safety of paracetamol and ibuprofen in the 1879 children with asthma 73 (defined as those receiving β-agonists, theophyllines or inhaled steroids on the day before trial recruitment). The authors found no evidence of increased hospital admissions or outpatient attendances for asthma associated with ibuprofen compared with paracetamol.…”

Section: Serious Adverse Eventsmentioning

confidence: 99%

Paracetamol and ibuprofen for the treatment of fever in children: the PITCH randomised controlled trial

Hay

Redmond²,

Costelloe³

et al. 2009

Health Technol Assess

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How to obtain copies of this and other HTA programme reports An electronic version of this publication, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). A fully searchable CD-ROM is also available (see below).Printed copies of HTA monographs cost £20 each (post and packing free in the UK) to both public and private sector purchasers from our Despatch Agents.Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per monograph and for the rest of the world £3 per monograph.You can order HTA monographs from our Despatch Agents:-fax (with credit card or official purchase order) -post (with credit card or official purchase order or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you either to pay securely by credit card or to print out your order and then post or fax it. Contact details are as follows: Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to Direct Mail Works Ltd and drawn on a bank with a UK address. Paying by credit cardThe following cards are accepted by phone, fax, post or via the website ordering pages: Delta, Eurocard, Mastercard, Solo, Switch and Visa. We advise against sending credit card details in a plain email. Paying by official purchase orderYou can post or fax these, but they must be from public bodies (i.e. NHS or universities) within the UK. We cannot at present accept purchase orders from commercial companies or from outside the UK. How do I get a copy of HTA on CD?Please use the form on the HTA website (www.hta.ac.uk/htacd.htm). Or contact Direct Mail Works (see contact details above) by email, post, fax or phone. HTA on CD is currently free of charge worldwide.The website also provides information about the HTA programme and lists the membership of the various committees. HTA NIHR Health Technology Assessment programmeT he Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service'. The HTA programme is needs led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of projects. First is the commissioned route. Suggestions for research are actively sought from people working in t...

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Section: Serious Adverse Eventsmentioning

confidence: 99%

Paracetamol and ibuprofen for the treatment of fever in children: the PITCH randomised controlled trial

Hay

Redmond²,

Costelloe³

et al. 2009

Health Technol Assess

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show abstract

“…11 There is, however, significant controversy regarding the importance of these challenge-derived findings for selected patients in the routine treatment of children with asthma. Lesko et al 12 showed a decrease in outpatients visits for asthma exacerbations among asthmatic children after short-term use of ibuprofen and definitely no increase in the rate of hospitalization for these children. A recent review of the subject even suggested that ibuprofen, as an antiinflammatory medication, may be of use in the treatment of acute exacerbations among asthmatic children 13 In recent years, a new classification of NSAID hypersensitivity has been proposed 14 and extended to the pediatric age group.…”

mentioning

confidence: 98%

Early Presentation With Angioedema and Urticaria in Cross-reactive Hypersensitivity to Nonsteroidal Antiinflammatory Drugs Among Young, Asian, Atopic Children

et al. 2005

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ABSTRACT. Objective. Nonsteroidal antiinflammatory drugs (NSAIDs), mainly ibuprofen, are used extensively among children as analgesic and antipyretic agents. Our initial survey in the Kendang Kerbau Children's Hospital in Singapore showed NSAIDs to be the second most common adverse drug reaction-causing medications among children of Asian descent. We attempted to characterize the clinical and epidemiologic profile of NSAID reactions in this group of patients.Methods. A retrospective case series from a hospitalbased pediatric drug allergy clinic was studied. A diagnosis of NSAID hypersensitivity was made with a modified oral provocation test. Atopy was evaluated clinically and tested with a standard panel of skin-prick tests. We excluded from analysis patients with any unprovoked episodes of urticaria and/or angioedema, patients <1 year of age, and patients who refused a diagnostic challenge test.Results. Between March 1, 2003, and February 28, 2004, 24 patients, including 14 male patients (58%) and 18 Chinese patients (75%), with a mean age of 7.4 years (range: 1.4 -14.4 years), were diagnosed as having crossreactive NSAID hypersensitivity. A family history consistent with NSAID hypersensitivity was elicited for 17% of patients. None of the patients reported any episodes of angioedema/urticaria unrelated to NSAIDs. The median cumulative reaction-eliciting dose was 7.1 mg/kg. Facial angioedema developed for all patients (100%) and generalized urticaria for 38% of challenged patients, irrespective of age. There was no circulatory compromise, but respiratory symptoms of tachypnea, wheezing, and/or cough were documented for 42% of patients. A cross-reactive hypersensitivity response to acetaminophen was documented for 46% of our patients through their history and for 25% through diagnostic challenge. Compared with patients with suspected adverse drug reactions to antibiotics, patients in the NSAID group were older (7.4 vs 4.8 years) and more likely to have a diagnosis of asthma (odds ratio: 7.5; 95% confidence interval: 3.1-19).Conclusions. Early presentations of facial angioedema and urticaria are key features of dose-and potency-dependent, cross-reactive reactions to NSAIDs in a subpopulation of young, Asian, atopic children. Significant overlap with acetaminophen hypersensitivity, especially among very young patients, for whom the use of a cyclooxygenase-2-specific medication may not be feasible, severely limits options for medical antipyretic treatment. A spirin and other nonsteroidal antiinflammatory drugs (NSAIDs) are a widely used group of medications whose mechanism of action involves inhibition of prostaglandin production through blockade of the cyclooxygenase (COX) enzymes known as COX-1 and COX-2. This blockade also results in the shunting of arachidonic acid metabolism toward the 5-lipoxygenase pathway, resulting in increased production and release of cysteinyl leukotrienes.Acetaminophen, the most ubiquitously used antipyretic medication for children worldwide, is an "old" medication whose mechanism of a...

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“…The standard clinching way to assess causality Table 1 The consistency of interdisciplinary evidence makes the causal association between asthma and acetaminophen plausible enough to change prescription practice (in paediatrics): McBride (2011) 1. Strength of the association [57][58][59] 2. Robustness of association across geography, culture and age [51,[53][54][55][60][61][62][63] 3.…”

Section: Case Study: the Paracetamol Enigma In Asthmamentioning

confidence: 99%

“…Robustness of association across geography, culture and age [51,[53][54][55][60][61][62][63] 3. Dose-response relationship between acetaminophen exposure and asthma [58,59] 4. Coincidence of time trends in acetaminophen use and asthma increase [64] 5.…”

Section: Case Study: the Paracetamol Enigma In Asthmamentioning

confidence: 99%

Causal Assessment of Pharmaceutical Treatments: Why Standards of Evidence Should not be the Same for Benefits and Harms?

Osimani

Mignini

2014

Drug Saf

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It is increasingly acknowledged both among epidemiologists and regulators that the assessment of pharmaceutical harm requires specific methodological approaches that cannot simply duplicate those developed for testing efficacy. However, this intuition lacks sound epistemic bases and delivers ad hoc advice. This paper explains why the same methods of scientific inference do not fare equally well for efficacy and safety assessment by tracing them back to their epistemic foundations. To illustrate this, Cartwright's distinction into clinching and vouching methods is adopted and a series of reasons is provided for preferring the latter to the former: (1) the need to take into account all available knowledge and integrate it with incoming data; (2) the awareness that a latent unknown risk may always change the safety profile of a given drug (precautionary principle); (3) cumulative learning over time; (4) requirement of probabilistic causal assessment to allow decision under uncertainty; (5) impartiality; and (6) limited and local information provided by randomised controlled trials. Subsequently, the clinchers/vouchers distinction is applied to a case study concerning the debated causal association between paracetamol and asthma. This study illustrates the tension between implicit epistemologies adopted in evaluating evidence and causality; furthermore, it also shows that discounting causal evidence may be a result of unacknowledged low priors or lack of valid alternative options. We conclude with a presentation of the changing landscape in pharmacology and the trend towards an increased use of Bayesian tools for assessment of harms. Key PointsCausal assessment and scientific inference in pharmacology: inductivist approaches fare better than hypothetico-deductive ones when dealing with harms

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Asthma Morbidity After the Short-Term Use of Ibuprofen in Children

Cited by 175 publications

References 15 publications

Paracetamol and ibuprofen for the treatment of fever in children: the PITCH randomised controlled trial

Paracetamol and ibuprofen for the treatment of fever in children: the PITCH randomised controlled trial

Early Presentation With Angioedema and Urticaria in Cross-reactive Hypersensitivity to Nonsteroidal Antiinflammatory Drugs Among Young, Asian, Atopic Children

Causal Assessment of Pharmaceutical Treatments: Why Standards of Evidence Should not be the Same for Benefits and Harms?

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