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Oral tramadol: children still being exposed to the risk of overdose

A concentrated solution of oral tramadol carries a risk of significant overdose through its error-prone dropper.

In 2020, France's Centre-Val de Loire regional pharmacovigilance centre reported the case of a 10 year-old child who was admitted to the emergency department for drowsiness that had been progressing since breakfast-time. His pupils were abnormally constricted and respiration was slow.

The child had been prescribed oral tramadol (Topalgic°) for pain related to an injury. The parents had administered this oral solution as a “syrup”, by collecting drops into a teaspoon. The amount taken by the child that morning was estimated as 3 ml, i.e. 300 mg of tramadol instead of the 20 mg prescribed (8 drops).

This serious error can be understood by analysing the two brands of oral tramadol marketed in France (Contramal° and Topalgic°), which both use the same packaging and labelling. The dose is 1 mg of tramadol per kg body weight, i.e. only 0.4 drops per kg. An error of a few drops therefore carries a risk of serious consequences in young children. 

Tentative measures taken in 2016 by the French Health Products Agency (ANSM) largely transferred responsibility for managing the risk of errors to those involved in the final steps of the medication-use process, namely healthcare professionals, and the patients or carers. Upstream actions by the companies are, however, possible. A less concentrated oral solution would reduce the magnitude of overdoses, and the dose volume would be larger, enabling the use of oral syringes graduated in clearly marked milligrams of tramadol, with a capacity not exceeding the maximum dose to be administered.

Until decisive improvements have been made, if tramadol is chosen despite its dangers and its often uncertain value, the number of drops to be administered at each dose must be specified, both verbally and in writing, when prescribing or dispensing this drug. And it is crucial to make sure this is fully understood by the child’s family and carers.

©Prescrire 1 October 2021

Source: "Tramadol oral drops: children still being exposed to accidental overdose" Prescrire International 2021; 30 (230): 242. Subscribers only.

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