Banned food additives found in baby medicine

[Al-khiyal]

March 10 2007 -- Everyday children's medicines found in cupboards up and down the country contain a "cocktail of additives" banned from foods and drinks for youngsters of the same age, a food watchdog has claimed.

Brands widely used by parents such as Calpol, Benylin, Sudafed, and Tixylix have all fallen foul of a survey of medicines for infants under three, amid concerns manufacturers are using synthetic ingredients unnecessarily.

The survey, by the Food Commission, found many products routinely contain colourings and multiple artificial sweeteners and preservatives, which could have harmful side effects.

Of 41 medicines scrutinised, just one product was found not to contain a food additive or additives which are prohibited from foodstuffs manufactured for infants under 36 months. That was Superdrug's own label children's dry cough syrup.

Potential side effects of the additives - such as E123, E214, E216, and E218 - include delayed allergic reactions, irritation of the skin, eyes and mucosal surfaces, stomach upsets, laxative effects, and diarrhoea.

Nigel Meadows, a paediatric gastroenterologist currently treating a young child with an allergy to a paracetamol product, told The Herald that the use of additives to make medicine more palatable to children had run its course, and called on the pharmaceutical industry to launch a review of childhood medicine.

Ian Tokelove, spokesman for the commission's Food Magazine, said: "It seems that the food manufacturers and drug manufacturers operate under different rules, which is crazy. Smarties manufacturer Nestle cleaned up its act, and if the food manufacturers can do it why can't the pharmaceutical industry? Whilst many children will be able to consume these products safely, there will be those who will suffer allergic reactions to additives.

"It is time for medicine manufacturers to clean up their act and remove any unnecessary additives. We believe that colourings and artificial sweeteners can be replaced with natural alternatives, and the use of preservatives should be rigorously questioned."

Just over half the medicines warned of possible side effects linked to the consumption of specific food additives.

Dr Meadows, a consultant at the Royal London Hospital, said: "Additives and colourings were introduced to make medicine easier for children to take, but more and more, we are seeing allergic reactions.

"I am treating one young child allergic to Calpol paracetamol, and I'm looking to break down the individual components to source the allergy. It is time the industry looked more closely at the use of additives in children's medicine, and whether these ingredients are necessary at all."

Food and drink manufacturers tend to adhere to 1992 guidance issued by the government that natural flavourings only should be used in foods for young infants, but the report claims that "some medicine manufacturers think it is OK for babies to be exposed to artificial flavourings".

The Medicines and Healthcare Products Regulatory Agency (MHRA), the body responsible for the regulation of medical products in the UK, said that in accordance with European legislation, it permits the inclusion of additives, including colourants, in foods and drugs. The MHRA added that the "function and usefulness" of all such additives in medicines must be justified before a licence to market products is granted.

The survey found azo dyes were present in five items out of 41 surveyed.

Preservatives were discovered in all but 10 of the medicines surveyed. Sweeteners were found in 37 of the 41 medicines.

A spokesman for Calpol said last night: "Almost all medicines contain colouring and flavouring agents to enable consumers to identify them and to make them more acceptable to take, disguising the less palatable taste of the active ingredient."

He added: "This is particularly relevant with children's medicines, as ensuring children take their medicine is important to parents."

Banned food additives found in baby medicine

[Al-khiyal]

Medicines for babies and young children frequently contain additives banned from foods and drinks aimed at under-threes, research shows.

The Food Magazine examined 41 medicines aimed at the under-threes, and found only one was free of the additives.

Azo dye colourings were found in five products and multiple artificial sweeteners and preservatives in many.

No colours or sweeteners are allowed in foods and drinks for the under-threes and most preservatives are banned.

Only additives strictly necessary from a technological point of view and recognised as being without risk to the health of young children are authorised in such foods.

The survey found four azo dye colourings, eight benzoate and two sulphite preservatives, and six sweeteners contained in the products examined.

Preservatives were present in all but ten, and sweeteners in all but four of the medicines surveyed.

Side effects

Some medicines warned the additives they contained could have harmful side effects.

The side effects listed included irritation of the skin and eyes, stomach upset and diarrhoea.

The Food Magazine is published by the Food Commission, an independent body campaigning for safer food in the UK.

Spokesman Ian Tokelove said: "Whilst many children will be able to consume these products safely, there will be those who will suffer allergic reactions to these additives.

"It is time for medicine manufacturers to clean up their act and remove any unnecessary additives."

Mr Tokelove said colourings and artificial sweeteners could be replaced with natural alternatives.

He also questioned the need to use preservatives at all.

Palatability

Medicines and Healthcare products Regulatory Agency said the use of all additives in medicines had to be justified by the manufacturer before a licence was granted.

However, most medicines could not be manufactured, stored or administered without some additional ingredients.

"Medicines can be quite unstable such that preservatives and other additives are necessary to maintain product quality for a reasonable shelf-life.

"Many medicines also have a very unpleasant taste and require sweeteners and other flavours to help ensure palatability, especially for children.

"Some patients have to take multiple medicines and find that easy identification by colour and other means helps ensure they take the right medicine at the right time."

Helen Darracott, of the Proprietary Association of Great Britain, said: "Unlike foods, additives in medicines are in very small quantities and are only taken for a short period of time.

"If the MHRA decides a product contains additives that are not strictly necessary, it will request that the medicine is re-formulated before it can be given approval."

Child medicine additive concern

[Bent_Bladi]

That is so scary! What the hell is going on with the FDA?! working on bribes now?!! ... poor babies

I wonder what banned additives are in our medicine ?

[Al-khiyal]

One of the first things you learn when you become a parent is that worry and concern can be part and parcel of the job, especially when it comes to meeting your child’s basic needs, such as health and nutrition.

When a child is ill, many parents will reach for one of the many medicines specifically sold for young children – but how many parents will read through the complicated small print where the ingredients, and sometimes the possible side-effects, are listed?

Having long campaigned against the use of unneccessary additives in food and drink The Food Magazine has now investigated the use of additives in infant medicines and has found that a plethora of artificial sweeteners, preservatives and colours are routinely added to medicines for babies and young children – despite such additives being banned from foods designed for the under threes.

Working out what is in your child’s medicine is not easy, as a full ingredients list is frequently only available inside the package, rather than listed on the outside. Ingredients listings were not legally required until 1993, when years of campaigning by the Hyperactive Children’s Support Group finally forced the disclosure of medical ingredients. We took a look inside the packets and here is what we found.

Survey results

The Food Magazine surveyed 41 medicines designed for consumption by children under three years old. The survey found four azo dye colourings, eight benzoate and two sulphite preservatives, and six sweeteners. All are banned from food and drink specifically designed for consumption by children under three years old.

Azo dyes were found in only a small number of medicines. These were Anbesol teething gel, Buttercup Infant cough syrup, Calpol Paracetamol, Sudafed Children’s Syrup and Superdrug Children’s Chesty Cough Syrup.

Preservatives were much more common and were present in all but ten of the medicines we surveyed. Where preservatives were present they were invariably benzoates. Tixylix Night Cough syrup (1yr+) managed to include both benzoate and sulphite preservatives.

Sweeteners were found in all but four of the medicines. Morrisons Junior Paracetamol and Superdrug Junior Paracetamol Suspension (both 3mths+) each contained four different sweeteners.

Artificial colours

Colouring additives are banned from foods and drinks for children aged under thirty six months of age, but we found plenty of unnecessary colourings in everyday infant medicines. Perhaps the most contentious colourings are the azo dyes, which we found in products such as Calpol paracetamol, Anbesol teething gel and Buttercup Infant Cough syrup. We found only one product warning that, “The colouring in this product (E124) may cause allergic reactions, including asthma.”

There is an increasingly wide range of natural colourings which food and drink manufacturers can turn to, rather than using these synthetic and questionable azo dyes. If Smarties can clean up their act - why can’t these medicines?

Artificial sweeteners

Sweeteners are banned from foods and drinks for children aged under 36 months, but almost every infant medicine we looked at contained artificial sweeteners, often as one of the major ingredients. Like azo dyes, sweeteners are controversial additives which some parents might wish to avoid.

The sweeteners sorbitol, maltitol and xylitol can have a laxative effect at high doses and some medicines warned of this e.g. “This product contains maltitol liquid which may have a mild laxative effect”.

Preservatives

We found a wide range of preservatives in infant medicines which are not allowed in foods and drinks for children aged under 36 months. Benzoate preservatives (E210 through to E219) were the most common. Many medicines warned in the small print that such preservatives could have unpleasant side effects e.g., “...contains sodium benzoate, which may irritate the skin, eyes and mucosal surfaces, and methyl hydroxybenzoate, which may cause skin reactions such as contact dermititis and more rarely wheezing.”

Some, but not all products, also warned that reactions to benzoates can be delayed and thus harder to link to the consumption of the medicine e.g., “Methyl hydroxybenzoate may cause allergic reactions such as skin rash; this may occur after a few days.”

We also found sulphite preservatives in one product, which did at least warn (in the small print) that, “Sulphites may rarely cause hypersensitivity reactions and bronchospasms (contraction of the airways).”

Although banned from foodstuffs for those under three years old, sulphites are very widely used across all processed foods and drinks (including alcohol) but it is rare to find any warning of the possible side effects caused by their consumption.

Artificial flavours

Many of the children’s medicines we looked at contained flavourings, which in themselves are additives. There is no specific legislation regarding the use of flavourings in food for the under threes, and the issue was last addressed in 1992 when the Food Advisory Committee advised the Ministry of Agriculture, Fisheries and Food that only natural flavourings should be used in foods for young infants. Thus natural vanilla should be used rather than synthetic vanillin, and orange oil used instead of orange flavouring.

Foods and drinks aimed at young children tend to stick to this guidance, but clearly some medicine manufacturers think it is okay for babies to be exposed to artificial flavourings.

In our table, we have indicated which medicines contain flavourings, but with only very limited information it is often impossible to differentiate between a natural plant extract or more cryptic flavourings such as Custard 570514E, Raspberry 500251E and Blackberry 50225E.

Chloroform

We found chloroform on the list of ingredients in Meltus Dry Coughs syrup. It is not included as an ‘active’ ingredient but rather as an ‘inactive’ ingredient, so one has to wonder what it is doing there. The Chloroform in Food Regulations of 1980 make it an offence to sell or import food containing added chloroform, but here it is in a child’s cough medicine.

Regulation

In the UK, the regulation of medical products is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA). We asked the MHRA why the additives found in our survey are permitted in medicines for babies and young children when they are specifically banned in foods and drinks for infants under 36 months old.

We also inquired why pharmaceutical companies use artificial flavours rather than natural flavours and inquired as to the MHRA’s position on the use of chloroform in children’s cough medicine.

The MHRA failed to respond fully to our questions, but stated that, “In accordance with European Legislation, the Medicines and Healthcare products Regulatory Agency permits the use of additives, including colorants, such as those with E-numbers, which have been approved for use in foods and in pharmaceuticals.”

The MHRA also told us that, “The function and usefulness of all additives in medicines must be justified by the manufacturer before they can get a licence to market the particular medicine. The evaluation takes into account the quantity of additives, the frequency with which the medicine will be used and the medical condition to be treated. Most medicines cannot be manufactured, stored and administered without some additional formulation ingredients. Unnecessary additives are discouraged and the manufacturer may be required to re-formulate the medicine before it can be approved.”

Additives can be reduced

Contrary to the MHRA statement that, “...unnecessary additives are discouraged,” our survey shows that artificial additives are widely used when there is no technological requirement for them to be there at all.

For instance, it is quite possible to flavour medicines with natural oils or extracts, and natural colourings such as beetroot and beta-carotene can be used instead of azo dyes. If parents were advised to give these medicinal products at mealtimes the manufacturers could also add a little sugar to sweeten their products, rather than relying on artificial sweeteners.

Preservatives are used to increase shelf life, as well as prevent any risk of the product becoming dangerous to health. But let us not forget that none of the preservatives which we list in the table would be permitted in foodstuffs for the under threes. Preservatives are highly active chemical compounds, designed to kill living organisms. As such the use of preservatives needs to be tightly controlled.

Providing medicines in sealed sterile sachet format, or advising refrigeration after opening a product, would help to negate the need to use preservatives. We noted that some medicines found in the survey contain no preservatives at all, whilst similar products contain two or three.

What needs to be done?

Giving one’s baby or young child a medicine that contains artificial additives, which are banned from the food they eat, can cause concern to a parent. But with little or no medical alternative and a baby in pain and discomfort, parents are frequently left with no choice.

It is time for the pharmaceutical industry to clean up its act and stop using questionable additives in their products, particularly those aimed at growing, developing infants. Legislation clearly prohibits the use of most additives in foods and drinks for the under threes. We urge the MHRA to take steps to ensure that in future, all medicines aimed at babies and young children are free of such additives.

A spoonful of sugar?

[Al-khiyal]

Open or download an Excel spreadsheet showing details of all medicines surveyed.

This spreadsheet lists the medicines, additives and any warnings regarding possible side-effects.

Charles Hendry MP has told us he intends to take up the issue of additives in children's medicines with the Secretary of State for Health, Patricia Hewitt MP and intends to table a question regarding the unnecessary use of additives in medicines.

If you want to write to the MHRA about the use of additives in medicines, please write to The Information Centre, MHRA, 10-2 Market Towers, 1 Nine Elms Lane, London, SW8 5NQ or email info@mhra.gsi.gov.uk

The Food Magazine

[Cheba_Mami]

People expect all medicines to be safe, this is really shocking!