Adverse Drug Reactions in Children from Mucolytic Drugs
Author Information
Author(s): Mallet Pauline, Mourdi Nadjette, Dubus Jean-Christophe, Bavoux Françoise, Boyer-Gervoise Marie-José, Jean-Pastor Marie-Josèphe, Chalumeau Martin
Primary Institution: Université Paris Descartes, Assistance Publique – Hôpitaux de Paris, Paris, France
Hypothesis
What are the paradoxical respiratory adverse drug reactions associated with acetylcysteine and carbocysteine in pediatric patients?
Conclusion
The benefit-risk ratio of mucolytic drugs in infants is likely negative based on the evidence of adverse reactions.
Supporting Evidence
- The study identified 59 cases of respiratory adverse drug reactions in children after exposure to mucolytic drugs.
- 86% of the children required hospitalization due to the adverse reactions.
- One patient died from pulmonary edema considered secondary to mucus vomiting.
Takeaway
Some cough medicines can make babies sicker instead of helping them, so doctors and parents need to be careful about using them.
Methodology
The study analyzed cases of respiratory adverse drug reactions reported to the French pharmacovigilance system from 1989 to 2008.
Potential Biases
Protopathic bias may affect the interpretation of the relationship between drug use and adverse reactions.
Limitations
The study could not evaluate the frequency of respiratory ADRs among pediatric patients due to the limitations of spontaneous reporting systems.
Participant Demographics
All participants were children younger than 6 years, with a median age of 5 months.
Digital Object Identifier (DOI)
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