Call to ban additives in children's medicines

Behind the Headlines

Tuesday October 22 2013

There is no evidence that the medications mentioned in the report are unsafe

Artificial colourings have been linked to hyperactivity

"Child medicines contain banned additives linked to hyperactivity," reports The Independent. The news is based on a report by pressure group Action on Additives, which?highlights the fact that additives banned from food are still found in children's medicines.

The report investigated which children's medicines contain particular colourings or preservatives linked to attention deficit disorders such as hyperactivity.

"The Hidden Additives in Children's Medicines (PDF, 192kb)" report?says that medicines that can be given to children as young as two months of age may contain colourings that the UK government requested?were?withdrawn from all food and drink.

These additives consist of six specific colourings and one preservative that have been linked to attention deficit disorders, including hyperactivity in children and the general population. The additives?have been dubbed the "Southampton Seven" because the link to these disorders was discovered by researchers in Southampton.

As a result of this research, the Food Standards Agency (FSA) requested a voluntary withdrawal of the use of these additives by food and drink manufacturers in the UK. The additives linked to behavioural problems in some children are:

  • Tartrazine (E102)
  • Quinoline Yellow (E104)
  • Sunset Yellow (E110)
  • Carmoisine (E122)
  • Ponceau 4R (E124)
  • Allura Red AC (E129)
  • Sodium benzoate (preservative; E211)

One of the manufacturers mentioned in the report, Johnson & Johnson, which makes Calpol, has been quoted in the media as saying: "The consumption of food and drink is very different to the consumption of medicines. Over-the-counter medicines are only intended for occasional use in small quantities over a very short period of time."

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Are these additives actually banned?

The report states that the use of artificial colours in any foods, especially those prepared for infants and young children under the age of 36 months, has been banned in the European Union for more than 20 years.

For other foods and drinks, European regulation requires those containing the "Southampton Seven" additives to be clearly labelled to show they contain ingredients that could have an adverse health effect.

However, medicines have different regulations from food and drink, and the complete ban on colourings, flavourings, sweeteners and preservatives in food and drink for young children up to the age of 36 months does not apply to medicines.

The MHRA, the UK government agency responsible for regulating all medicines???including making sure medicines work and are safe???has encouraged manufacturers of medicines to remove the "Southampton Seven" additives where possible.

The report indicates that the MHRA has said that medicines are taken infrequently and therefore consumption of these ingredients is likely to be low.

However, Action on Additives says that there is little evidence that this is true, for example, in the case of chronically ill children requiring daily doses of medicine.

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Who produced the report?

The report was produced by a campaign group called?Action on Additives, which is funded by charitable and research grant funding.

According to its website, it provides evidence-based information and resources about the use of colourings, sweeteners, flavourings and other ingredients in the UK's food supply.

The Action on Additives website says it is a project of First Steps Nutrition Trust, which supports good nutrition from pre-conception to five years.

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What evidence does the report provide?

The report details the findings of an Action on Additives investigation into prescription and over-the-counter medicines, with particular attention on medicines for children. The report set out to learn how many medicines included one or more of the "Southampton Seven" additives. They found:

  • the most frequently used colouring was Sunset Yellow (E110), used in six products
  • the red colour Carmoisine (E122) was used in four medicines, including Calpol Paracetamol Infant Suspension, which is designed for infants as young as two months, and Boots Paracetamol 3 Months Plus
  • five medicines contained either Quinoline Yellow (E104) or Ponceau 4R (E124)
  • two of the six "Southampton" colourings were not used in medicines for children (Tartrazine E102 and Allura Red AC E129)
  • the preservative Sodium benzoate (E211) was used in 37 different children's medicines

The report says that artificial colours used in foods, drinks and medicines do not have nutritional or safety benefits. It says they are used as "cosmetic" additives to boost the consumer appeal of products, for example by adding brightness or suggesting the presence of an ingredient such as a fruit.

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What actions has the report called for?

The Action on Additives campaign has called for retailers and manufacturers to do more about banning the use of the "Southampton Seven" additives in their products.

Specifically, it wants stronger action from the regulatory agencies in the UK and Europe so that the artificial colourings investigated in the Southampton research are banned from food and medicine and not simply "recommended for withdrawal".

It has said that in the meantime it should be a requirement that medicines contain information on their label if they contain artificial colourings or preservatives.

The campaign group has also called for:

  • lobbying for better regulation and sharing of information about upcoming changes in regulation or new testing as it becomes available
  • the distribution of?a guide for parents to help them avoid additives in children's medicines

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How have medicines regulators responded?

Dr Siu Ping Lam, the MHRA's Acting Director of Licensing, said: "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.

"The quantities used in, and consumed from, medicines is also comparatively small compared to foods.

"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."

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How accurate is the media's reporting of the study?

The story was widely covered in the UK media and was reported appropriately.

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Conclusion

Whether adding artificial colourings to medicines is justified is a legitimate matter of debate. But it is important not to lose sight of the fact that all of the medicines mentioned in the report are effective in treating childhood diseases.

The link between?hyperactivity and the concentrations of these additives used in medicines remains unproven.

Considering the available evidence, it is reasonable to say that if your child is ill, the benefits of using these medicines are likely to outweigh any potential risks.

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Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on Twitter.

Analysis by Bazian

Edited by NHS Choices

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