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Premature babies exposed to toxins in liquid medicines

Liquid medicines commonly given to premature babies and infants contain potentially harmful substances - and sometimes at levels above those recommended for adults - reveals a study published ahead of print in the fetal and neonatal edition of Archives of Disease in Childhood.

Babies born early have a much higher risk of a range of diseases and complications associated with their prematurity than babies born after a normal length pregnancy. Liquid medicines are the usual formulation used to treat them as babies cannot swallow pills.

Many contain agents, known as “excipients.” These are used to ease the administration, absorption or preservation of the active substances or improve the taste and appearance of the medicine.
The babies were treated for between 2.5 and 9 weeks, and given a range of treatments, from iron and vitamin drops to furosemide and dexamethasone.

During this time, they were regularly exposed to 20 different excipients, including ethanol (found in iron and furosemide) and propylene glycol (found in dexamethasone), chemicals that have the potential to cause nerve damage.

Seven of them had severe lung disease as a result of their prematurity, and these babies were exposed to higher levels of excipients than the babies without this problem.

The UK Food Standards Agency has recommended the removal of the colourant Ponceau 4R, because of concerns about its effect on neurodevelopment and behaviour. This agent was found in the iron formulation given to the infants.

The authors point out that children’s medicines have to cater for a wide age range, making it difficult for manufacturers to tailor their products for each age group. The inclusion of some excipients is also a necessity.

But they conclude: “We feel it is important that the [medicines regulators] not only ensure that all manufacturers provide detailed labelling of the excipient content of their products but all lead action to determine whether existing practice constitutes a risk, and if so, how this might be dealt with.”

Archives of Disease in Childhood