Parents of a three-month-old boy, weighing 5 kg, phoned the Victorian Poisons Information Centre for advice. The child had just woken up from a big sleep; he was now flushed, cranky and unsettled. Three hours earlier he had been given 5 mL of Donnalix Infant Drops instead of 0.5 mL. The parents were advised to take the child to the nearest hospital.
A two-month-old boy, weighing 4 kg, was brought to a hospital emergency department. He had dilated pupils, a dry mouth, a heart rate of 200 beats/minute and was a little sleepy. Ninety minutes earlier, he had been given 2 mL of Donnalix Infant Drops, instead of the correct dose of 0.4 mL. The child required overnight admission for observation.
A one-year-old girl, weighing 10 kg, was given three 10 mL doses of Donnalix Infant Drops instead of the correct dose of 1 mL. She presented to hospital with dilated pupils slowly reacting to light, a heart rate of 150 beats/minute, and difficulty feeding. The child required observation, with cardiac monitoring, and supportive care until her symptoms resolved.
Medical, nursing and pharmacy staff need to be aware that dosing errors can occur with Donnalix Infant Drops, particularly giving 10 times the correct dose. Members of the public often assume that because over-the-counter medicines are not regulated by prescription, they are safe, even in overdose.4
In view of the potential for toxicity and the absence of a compelling clinical indication we believe Donnalix Infant Drops should be withdrawn from the market. As this is unlikely to happen, parents or carers should be shown the correct dose at the time of purchase. A boxed warning about the importance of measuring the correct dose and a reduction in the 'strength' of the drops would further decrease the risk of mistakes. Restricting access by rescheduling Donnalix Infant Drops to a 'pharmacist only' or 'prescription only' medicine may further decrease the risk of dosing errors.
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- Pickford EJ, Hanson RM, O'Halloran MT, Fenwick D, Noble P, Mc Donald JD. Infants and atropine: a dangerous mixture. J Paediatr Child Health 1991;27:55-6.
- Tarabar AF, Hoffman RS. Pediatric toxic syndrome (toxidromes). In: Erickson TB, Ahrens WR, Aks SE, Baum CR, Ling L, editors. Pediatric toxicology: diagnosis and management of the poisoned child. 1st ed. New York: Mc Graw-Hill; 2005. p. 75-83.
- Cranswick N, Mc Gillivray G. Over-the-counter medication in children: friend or foe? Aust Prescr 2001;24:149-51.