Adverse events from cough and cold medications after a market withdrawal of products labeled for infants.
Pediatrics
; 126(6): 1100-7, 2010 Dec.
Article
em En
| MEDLINE
| ID: mdl-21098150
ABSTRACT
OBJECTIVE:
A voluntary market withdrawal of orally administered, over-the-counter, infant cough and cold medications (CCMs) was announced in October 2007. The goal of this study was to assess CCM-related adverse events (AEs) among children after the withdrawal.METHODS:
Emergency department (ED) visits for CCM-related AEs among children <12 years of age were identified from a nationally representative, stratified, probability sample of 63 US EDs, for the 14 months before and after announcement of withdrawal.RESULTS:
After withdrawal, the number and proportion of estimated ED visits for CCM-related AEs involving children <2 years of age were less than one-half of those in the prewithdrawal period (1248 visits [13.3%] vs 2790 visits [28.7%]; difference -15.4% [95% confidence interval [CI] -25.9% to -5.0%]), whereas the overall number of estimated ED visits for CCM-related AEs for children <12 years of age remained unchanged (9408 visits [95% CI 6874-11 941 visits] vs 9727 visits [95% CI 6649-12 805 visits]). During both periods, two-thirds of estimated ED visits involved unsupervised ingestions (ie, children finding and ingesting medications).CONCLUSIONS:
ED visits for CCM-related AEs among children <2 years of age were substantially reduced after withdrawal of over-the-counter infant CCMs. Further reductions likely will require packaging improvements to reduce harm from unsupervised ingestions and continued education about avoiding CCM use for young children. Monitoring of CCM-related harm should continue because recommendations were updated in October 2008 to avoid the use of CCMs for children <4 years of age.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Antitussígenos
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Descongestionantes Nasais
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Resfriado Comum
/
Tosse
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Rotulagem de Medicamentos
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Recall e Retirada de Produto
/
Expectorantes
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Prognostic_studies
Limite:
Child
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Child, preschool
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Female
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Humans
/
Male
Idioma:
En
Revista:
Pediatrics
Ano de publicação:
2010
Tipo de documento:
Article
País de afiliação:
Estados Unidos