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Tramadol is often used in obstetrics for the relief of labour pain. It has a dual mechanism of action, a monoaminergic effect of tramadol itself and an opioid effect, primarily mediated by its metabolite O-desmethyl tramadol, formed by genetically polymorphic cytochrome P450 2D6. In newborns, elimination of O-desmethyl tramadol is prolonged due to immature renal function. We report on a case of neonatal death following rectal administration of tramadol to treat labour pain to a birth-giving mother. An objective causality assessment using the Naranjo probability scale revealed that the likelihood of tramadol causing respiratory depression was probable. We hypothesize that neonatal death was associated with an increased exposure to O-desmethyl tramadol due to ultrarapid metabolizer cytochrome P450 2D6 genotype of the mother. More evidence is needed to support this association. Nevertheless, in obstetric analgesia, tramadol should be used with more caution until more safety data are available.

Probable association of neonatal death with the use of tramadol to treat labour pain