UK: Suspect Food Additives Still Widely Used in Children's Medicine - Research

Research has confirmed a link between certain food additives and hyperactivity. Anna Glayzer investigates the use of these in children's medicines.

Many people in the UK will now know that research funded by the Food Standards Agency (FSA) has shown that certain food additives can increase hyperactivity in susceptible children. But, what they may not realise is that these additives can also be found in over-the-counter and prescription medicines commonly given to children.

Our campaign, Action on Additives, now has an ever-growing list of hundreds of products, including medicines, which contain these additives.

Using the online Electronic Medicines Compendium, The Food Magazine undertook a survey of five commonly prescribed types of children’s medicines (many of which are also available as over-the-counter medicines), to check if the suspect food additives were also used in children's medicine.

We looked at 70 medicines in total, all of which were suitable for the under twelves. 28 of these contained one or more of the suspect additives. 16 of the products which contained suspect additives were aimed at the under threes.

We have little control over the choice of prescription medicines which are prescribed to us and our families, so those who wish to avoid these food additives would find the task tricky to say the least.

The pharmaceutical industry argues that because the additives are used in such low quantities there can be no risk to children's health, and defends them on the basis that it is still perfectly legal to use them in foodstuffs. The fact that all of these additives are banned from food and drink for the under threes is simply ignored.

But, not all parents want their children to consume additives unless it is absolutely necessary. We spoke to Cathy Court, a mother of two and Director of the Netmums website, who told us that she found it, "really hard to find an antibiotic or a medicine for reducing fever that does not contain artificial colourings." Court, who has personal experience of dealing with hyperactivity in children, said, "I don’t care whether medicines are bright orange or pink, I just want a plain, uncoloured medicine that does its job. I don’t understand why manufacturers haven‘t responded with formulations for which there is clearly so much demand."

Interestingly, some companies are slowly responding to consumer pressure, but for most companies, the issue seems to be of little concern.

Adverse drug reactions

The Food Magazine spoke to the Proprietary Association of Great Britain (PAGB), the trade association for manufacturers of over-the-counter medicines and food supplements in the UK, about the issue of food additives in medicines.

When asked whether companies were cleaning up their act in regard to colours in medicines, the PAGB responded, "Companies take this issue seriously and since the findings of the study by the University of Southampton have been reviewing the use of additives in their products. This has included looking at Adverse Drug Reaction (ADR) reports in relation to additives. However, these reports have not provided any evidence to suggest that the use of such additives in medicines has caused any problems."

It is little wonder the ADR reports have not shown any problem. How many parents are actually aware of the 'yellow card scheme', administered by the Medicine and Healthcare products Regulatory Agency (MHRA)? The scheme allows patients to submit Adverse Drug Reaction reports directly to the MHRA, but is not mentioned anywhere on the packaging of medicines or on patient information leaflets. Anecdotal evidence suggests that many parents are concerned by the side effects apparently caused by medicines, but few would know how to report such effects.

Interestingly, the 'yellow card scheme' is only supposed to be used to report a suspected side effect that is not mentioned in the patient information leaflet that comes with the medicine. Since most medicines do carry warnings of possible allergic reactions to colours and preservatives, one could understand why a parent might not use the scheme to report an adverse reaction.

What are the alternatives?

The MHRA argues that colourings are necessary so that those who must take multiple medicines can use colour to identify the right medicine at the right time.

Steve Tomlin, Consultant Pharmacist at Evelina Children's Hospital, agrees with this, and also points out that, "Colours can be hard to avoid altogether. Natural colours are all well and good, but are they less likely to cause reactions?" Tomlin suggests that, "Avoidance where possible and awareness where not possible is the only real way ahead."

Tomlin's recognition that 'avoidance' and 'awareness' are the way ahead is a refreshingly frank and forward-thinking response, seemingly out of kilter with the pharmaceutical industry. Poor labelling of medicines means that ingredients lists are frequently only found inside packets, buried deep within the small print. Such labelling hinders both avoidance and awareness.

What does the future hold?

Food manufacturers have been reformulating products (or promising to do so) as consumers seek out products which are free of artificial colourings. Where the threat of legislation looms, such action increases rapidly. The European Food Safety Authority (EFSA) is currently reviewing the UK research that linked the seven suspect food additives to hyperactivity. If need be, EFSA can advise the European Parliament to ban their use in food and drink across Europe.

The MHRA tell us that they are awaiting "the review being carried out by European FSA," to see how it might impact on additives in medicines.

Meanwhile, in January 2008, the UK's Associate Parliamentary Food and Health Forum called for a ban on the use of, “substances of no nutritional value as foods or ingredients in foods.” If such a ban was to be undertaken, we would see artificial colourings disappear overnight.

Ultimately it seems that only a change in legislation, or at the very least a willingness from the MHRA to do something a little stronger than “discourage” unnecessary additives, will prompt the makers of children’s medicines to take this issue seriously. In the meantime, parents have no choice but to continue to buy the medicines that are available. Then of course, there is always the yellow card scheme.

Medicine manufacturers do little, or nothing

Since The Food Magazine exposed the use of banned food additives in children’s medicines in March 2007, several major brands have spent millions on relaunching or reformulating their products. But where did the money go?

In September 2007, Calpol introduced three new colour free variants to its range of children’s medicines. The packs make it very clear the products are colour free, but Calpol has failed to clean up older products, such as Calpol Infant Suspension (two months and over) which still contains the controversial azo dye E122, carmoisine.

Calpol clearly understands that consumers want children’s medicines to be free of colourings, but they will not risk removing the artificial colours from their more established brands. E122 is banned from food and drink for the under threes and has been linked to hyperactivity in susceptible children.

In October 2007, Benylin cough medicine announced a huge £8m relaunch campaign, ahead of the peak winter coughs and colds season. Benylin’s children’s cough medicines contain E211, sodium benzoate – another additive suspected of influencing hyperactivity in children and banned from food and drink for the under threes. So what did Benylin do with that £8m? They spent it on fresh packaging and bigger bottles, and did nothing to remove the additive from their children’s medicines.