A charity is calling for food colourings linked to hyperactivity to be banned from children’s medicines.
Action on Additives said 19 children’s medicines sold in the UK contain colourings that were linked with hyperactivity in a Southampton University study published in 2007.
The Food Standards Agency called for a voluntary ban on the “Southampton Six” - Sunset Yellow (E110), Quinoline Yellow (E104), Carmoisine (E122), Allura Red (E129), Tartrazine (E102) and Ponceau 4R (E124) - from food and drinks in 2008 as a result of the study.
Medicines are subject to different regulations which allow the additives to be included.
The Medicines and Healthcare Regulatory Agency (MHRA) has previously said that the medicines are intended to be taken infrequently, and therefore consumption of the additives is likely to be low.
At least one of the colourings Quinoline Yellow, Sunset Yellow, Carmoisine and Ponceau 4R are in 19 children’s medicines, including the widely used Calpol infant suspension and Boots paracetamol suspension.
Action on Additives said it had seen no studies relating to the effect of the additives on chronically ill children requiring daily doses of the medicines.
And it said anecdotal evidence from parents suggested that some medicines such as infant paracetamol suspensions were given to very young children frequently, with first intakes often associated with an infant’s first immunisations at eight weeks of age.
It is calling on manufacturers to withdraw the colourings from children’s medicines and asking regulators to consider a complete ban.
It is also publishing a parents’ guide to additives in children’s medicines on its website.
Action on Additives co-ordinator Lizzie Vann-Thrasher said: “We are concerned that some of our most trusted children’s medicines contain unnecessary colourings that have been linked to hyperactivity and attention deficit disorders.
“Manufacturers of children’s medicines should follow the example of the food and drinks industry and remove these colourings from children’s medicines.”
The MHRA’s acting director of licensing, Dr Sui Ping Lam, said: “The quantities of additives, including colours, used in and consumed from medicines are small in comparison to foods.
“Any additives must be justified by the manufacturer before any new medicine is licensed. All the ingredients of a medicine must be shown in the patient information leaflet and some, including certain colourings, must also be shown on the label.
“We are aware that some additives can cause an unwanted reaction in a small number of people and we are continually monitoring their safety profile. This helps us to provide accurate information about any risks to patients and healthcare professionals. We encourage anyone who has had an adverse reaction to report it to us through our Yellow Card reporting scheme.”
A Boots spokeswoman said: “At Boots UK, the safety of our customers is of paramount importance. All medicines sold in the UK, including Boots Pharmaceuticals, must be approved by the MHRA as safe and effective for their intended use.
“Colour additives are an important component of many medicines, as the colour of the product allows patients and healthcare professionals to identify a medicine on sight. One of the MHRA’s roles is to assure that colour and other additives used in medicines are safe and that the products containing these ingredients are appropriately labelled.”
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