Additives in infant medicines

Further to the recent show on food additives is this article from the BBC on additives in chidren's medicines.

Child medicine additive concern

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.

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

The manufacturers of medicines for the under-threes have insisted their products are safe.

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 10, 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.

AZO DYES
Azo dyes are synthetic compounds used to produce a wide range of colours
Tests suggest they produce only a very mild toxic effect - and are probably safe in the concentrations in which they are found in food
But research has linked the compounds to adverse reactions in people with aspirin allergy and asthmatics
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

Helen Darracott, of the Proprietary Association of Great Britain, the trade association for manufacturers of over-the-counter medicines, 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."

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."

Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/6433897.stm

Published: 2007/03/10 14:45:26 GMT

© BBC MMVII


Comment

While there may be different consumer and health legislation in the UK, the issue of additives in medicines is similar in Australia. While many children are on drugs for a short period of time there is a significant number who can be on them for months and sometimes years. The cumulative dose of the additives in these cases in particular need to be considered, however in a sensitive/allergy-prone child even single doses may cause behavioural changes, mood swings, rashes, atopic allergies etc.

Check all over the counter conventional and non-conventional medicines for colours, flavours, preservatives and sweeteners.

indigestion/reflux

Indigestion, reflux, heartburn, GERD/GORD – call it what you like but the short of if is that acid from the stomach goes in the wrong direction and irritates the oesophagus (the piece of plumbing between the mouth and stomach). There are many reasons why this may happen, often “too much stomach acid” is blamed but it must also bypass a sphincter in the lower oesophagus as well.

Some of the usual suspects in indigestion are: allergies, drug side effects (especially painkillers like NSAIDs), pregnancy hormones and pressure and stomach ulcers.

Reflux is almost as common in babies and infants as it is in adults but the symptoms of vomiting, crying, coughing, hiccoughing etc may often go undiagnosed. In 20-41% of infants diagnosed with Gastroesophageal reflux there is evidence of a cows milk allergy or intolerance. Food allergies are always suspected in babies with this condition.

In adults symptoms include – pain behind the breast bone, actual stomach acid rising in the oesophagus causing pain and irritation, a tickle at the back of the throat, persistent cough and hoarseness. The last two symptoms, when unaccompanied by an awareness of the others is sometimes termed “silent reflux” and may be misdiagnosed as asthma (though as reflux is a very common symptom, many asthmatics may have reflux as well).

Like babies’ food allergies are always likely in adults with reflux, however after a lifetime of eating an irritant food, the symptoms may appear stronger and more recalcitrant. Once you have reflux it is likely a whole host of foods will aggravate your condition – the most common are coffee (even decaf), chilli, alcohol and what I call “flour plus fat” (eg: pies, pastry, pasta, cakes, biscuits). But there are often other foods that may be your individual trigger – so a food diary is a good tool in tracking down the culprits.

Smoking is a big no-no. It severely aggravates this condition and could be a potential catalyst in upping the odds in developing cancer of the oesophagus.

And in case you skipped over it 2 paragraphs before – alcohol makes reflux really worse. If you want some relief from your symptoms, a little “detox” time makes good sense.


Reflux tips

If indigestion disturbs your sleep try raising the head of your bed to make it harder for the acid to flow back

Don’t eat for at least 2 hours before exercising

Watch your posture

Eat at a table, don’t multitask

Keep a food diary to track – food, drinks, stress, activities and symptoms

Follow the food guidelines above and consider having a break from dairy foods as well

Try good quality herbal teas: meadowsweet, liquorice, chamomile – 2-4 cups a day

Try 1-2 teaspoons of slippery elm powder mixed with water or mashed banana – before breakfast and before bed, or as required

Try a little diluted fresh cabbage and/or potato juice (strange but true)

Chew on a cell salt or tissue salt made from potassium and iron phosphate to relieve symptoms


Caveat: Long term, uncontrolled reflux can lead to permanent changes to the cells in the oesophagus, a condition known as Barrett Oesophagus. This carries a small risk factor of developing into oesophageal cancer. If you have severe reflux and wish not to take pharmaceutical drugs, you are advised to follow strict diet and lifestyle guidelines and have the appropriate diagnostic tests as recommended by your gastroenterologist.

Make up your own mind

This morning I was writing a piece about how the 'official' messages we get about food inform our choices even when they fly in the face of common sense. One aspect of this being the impact of corporate sponsorship on some of our professional associations and other authorities we look to for unbiased, nutritional advice. While taking a break I picked up yesterdays “Age” and came across one of those vox pop style bites, this time asking leaders in appropriate professions whether “We should ban junk food such as McDonalds?” There smiling at me was the pretty face of Alison Graham, spokeswoman for the Dieticians Association of Australia. If you represented the peak orthodox organization for nutrition what message would you give about not just junk food, but McDonalds in particular? Her response did not surprise me. In a piece of perfect spin she was quoted as saying, “It’s wonderful that we have such a diverse food supply in Australia, so we can’t take choice away from people. Fast food is more than deep fried fatty foods: it can be quick and convenient and it’s here to stay, but they’re not all bad choices – salads, sushi and wraps can all be healthy”.

Once more, the take home message is that fast, or junk, food can actually be healthy. Let’s ignore the direct issue of the deep fried, empty caloried most popular choices and shift the focus to something innocuous like sushi, which I could be wrong, but don’t believe is actually on the multinational in question’s menu. What is more it is one step away from saying it is UnAustralian if we banned fast food. Choice is important! The positive spin on the fast food industry would seem curious from a member of the Dieticians Association if you didn’t realise that although McDonalds are not direct sponsors of the Association, unlike the industries providing the meat and cheese for their burgers, but have donated generously by way of things like purchasing a stall at their annual conference. The quote obtained from the Association could not have been better written if a lobbyist for McDonalds had dictated it.

While many of us do not directly consult a member of the DAA to teach us about food choices, other than by well-placed media quotes their influence is reaches wider than we would imagine. Recently I spoke to a final year Medical Student at the country’s leading medical. We chatted about the course and how they were assessed. I asked directly about nutritional training and she happily informed me they had a whole semester on it now. “Fantastic a whole semester on how to eat!” No, I was informed, it was actually about digestion and a little nutrition got tagged on the end. “How then do you teach your patients about healthy food choices?” I enquired. To which she responded about the handing over of pamphlets from the Heart Foundation (the organization that McDonalds has now paid at least $330,000 a year for the privilege of a few of their well placed ‘ticks’) and the DAA. “Or”, she added “I’d send them to a dietician or nutritionist”. “I’m curious”, I asked, “what is the difference between the two?” She admitted to not know, but would refer them anyway.

This did not engender me with hope as to the future of orthodox nutritional advice. Does the sponsorship of the DAA, by Nestle (a leading manufacturer of infant formula and controversial for it’s work in the developing world) indirectly influence advice given to a breastfeeding mother? Would a registered dietician ever cite the many studies that repeatedly prove that milk or even high calcium intake does not reduces the risk of fractures nor prevent osteoporosis, when Dairy Australia is a generous sponsor of the Association? Would they point out the biggest study to date, observing 120,000 woman for more than 10 years, not only disproved the dairy-healthy bones link but went further to show the more milk you drank the higher your chances of developing ovarian cancer? Not mentioning a study in one thing, but actively promoting contradictory advice is another.

While individuals of a profession may not speak for every member, using high profile doctors to advertise a product sends a much more universal message. Although that toothpaste ad doesn’t show us the face of the dentist, the milk commercial with high profile GP, Cindy Pan more than trades on her reputation, using her as the face of all doctors. In a nifty and possibly subliminal twist it goes even further by using a Chinese woman it neatly subverts the contradictory message that the majority of Asians are lactose intolerant. We should all drink milk, Cindy the doctor, media personality and Asian tells us it will give us strong bones, so it must be true!

Recently I went shopping with my 80 year old father. He has only had to acquaint himself with the supermarket in recent years and is a good consumer, taking time to read labels and pour over information about food ingredients. Diligently he grabbed the low fat, high calcium milk, the “lite” potato chips and chose a frozen dinner based on the Heart Foundation Tick. When I tried to point out a similar meal that had better ingredients he refused due to its tick-less packaging. I stayed silent on the irony of someone who has a classic lactose allergy choosing a milk that has higher lactose than its full fat counterparts. As for the chips, why bother mentioning the “lite” actually referred to the flavour and well, if you cant have clogged arteries in your ninth decade of life, when can you?

The Soy Controversy

For the last decade the humble soya (soy) bean has alternately been portrayed as a hero and a villain. In Asia the prevalence of soy products in the traditional diet has been earmarked as the saviour of menopause and a strengthener of bones. In recent times there appears to be a dedicated campaign to show this food is a trigger of oestrogen dependent cancers, feminisation of boys and many other undesirable conditions.

It’s time to untangle the evidence for and against soy, and make some sense of why the sides are so divergent.

The Asian diet

Soy in the form of tofu, tempeh, miso, ‘milk’ or the cooked fresh or dried beans is a cornerstone of most Asian diets. Generally it is eaten regularly in small amounts. For example in Japan, a small bowl of miso, green soy pods (edamame), a splash of salty soya sauce or a handful of tofu cubes might be eaten most days. A traditional diet featuring soy in this way, also low or non-existent in dairy foods, has been associated with strong bones and not attracted any of the negative health connotations that have appeared in the West.

So if a small amount of soy is good for us, what about a large amount?

In the West serving sizes are markedly larger. Instead of tofu cubes, a large ‘steak’ may replace meat in a meal. Soy milk, instead of just the straight bean extracted in water, is turned into a sweeter, oily drink and drunk by the litre. In the name of being healthy, we have ‘supersized’ a super food.

What is more soy has entered the food chain increasingly as a food for livestock and as a ‘filler’ or bulking agent in some processed foods, meaning we are getting concentrated soy hits when we least expect it.

More than 60% of all processed food in Britain today contains soya in some form, according to food industry estimates. It is in breakfast cereals, cereal bars and biscuits, cheeses, cakes, dairy desserts, gravies, noodles, pastries, soups, sausage casings, sauces and sandwich spreads. Soya, crushed, separated and refined into its different parts, can appear on food labels as soya flour, hydrolysed vegetable protein, soy protein isolate, protein concentrate, textured vegetable protein, vegetable oil (simple, fully, or partially hydrogenated), plant sterols, or the emulsifier lecithin. Its many guises hint at its value to manufacturers.

Soya increases the protein content of processed meat products. It replaces them altogether in vegetarian foods. It stops industrial breads shrinking. It makes cakes hold on to their water. It helps manufacturers mix water into oil.

from The Guardian

Furthermore, as soy’s fame has spread – especially in it’s role as a phytooestrogen as a beneficial treatment for the symptoms of menopause, soy in a high dose, concentrated supplement form has been added to some people’s health regimes.

As awareness of issues with dairy products have spread, with more people discovering they are intolerant or allergic to this highly used food, soy often in large amounts of milk or pseudo-dairy such yoghurt, cheese or icecream has gained popularity. The humble bean has gone a long way.

But is soy really good for us?

In the last few years there has been some minor studies associating various soy derivatives with brain shrinkage (the Hawaiian geriatric study looking at tofu eaters, now considered to be unconvincing even by the anti-soy camp), feminisation of young boys (soy formula), thyroid conditions, infertility and even cancer.

At the same time studies continue to show positive health benefits of eating soy based foods such as helping prevent breast, prostate and possibly bowel cancer.

How can this be so?

Popular theories to explain these divergent viewpoints include: type and quantity of soy food in the diet, biased studies, broad hypotheses (if soy has an oestrogen like action, it must be ‘bad’ for oestrogen dependent cancers) and even rumours of misinformation from other industries who may be loosing some of their market share to soy foods.

Lets take a look at a few of the fears

Soy causes thyroid cancer: True and False: It has been known for a long time that a high soy diet may aggravate an existing underactive thyroid, though it has not been linked to cancer. This is termed a “goitregenic” food. Note that the cruciferous vegetables (of which brocolli and cabbage belong) are also goitregenic, yet are long associated with containing cancer preventing properties (indols).

Soy feminises little boys: Possibly. Does this cause any lasting negative effects? Undecided. Should you feed babies large amounts of soy? No. But this is largely because soy milk is not a breast milk substitute. Potentially all breast milk substitutes can be problematic. Furthermore approximately 1:4 dairy allergic children are also allergic to soy foods. I have witnessed an addiction like quality in some of these children, demanding over a litre of soy milk a day! I’d suggest that would be closer to an adult dose for a week. Soy milk is a relatively safe, calcium containing option to moisten cereal or use in cooking. The only ideal ‘milk’ in any large quantities for babies and toddlers is breast milk. For those who cannot be breast fed or are needing supplementation due to being picky eaters consider a low allergy formula. Cows milk is equally unsuitable and may be a source of exogenous hormones, allergies and a trigger of asthma, eczema, colic, hives and other common conditions.

Soy causes infertility in men: Unproven. This is based on a study when genistein (an isolated constituent of soy) was added to a live semen sample in a test tube. In 24 hours 1/3 of the sperm had died after being ‘sped up’ or hyperactive. The scientists concluded this may mean that sperm would not be able to swim properly and fertilize an ovum. At this point it seems to be a very wide hypothesis and not born out in any human studies.

Soy foods block the absorption of nutrients: True and False. Uncooked soy beans, edamame, contain a lot of phytates that are like ‘claws’ in plant foods that can affect nutrient absorption. Cooking fixes this problem. It is a similar issue in many grains and beans – foods which are rarely ever eaten uncooked.

The latest soy controversy is about soy supplements (ie: large, therapeutic doses of concentrated soy) and breast cancer. The study does not suggest soy containing foods are problematic (in fact some of us would suggest the opposite), yet the reporting of this story often featured soy foods. The concern is that pharmacological doses of soy may interfere with the bioavailability of the most commonly used drug used in the treatment of breast cancer. This is currently only an hypothesis, not proven in human studies.

The take home message.

There is no convincing evidence that eating moderate amounts of traditional soy foods in your diet will have negative health consequences, in fact they could offer many benefits (particularly around menopause in women). Phytooestrogens appear in many healthy vegetable based foods (beans, nuts, seeds etc) and it is interesting that soy has been singled out as being the bad guy in this argument. Almost all the negative studies involving soy fall into the category of not being on human, using isolates rather than the whole food sources, being hypothetical (if it has a weak oestrogen-like effect it will do all the negative things that oestrogen can sometimes do) or are statistically insignificant. The glaring exception is for people who have a goitre and the food guidelines include reduction of other healthy foods, not just soy.

Beyond genetic modification of soy (organic sources seem the safest option for now), the biggest health question mark hangs over soy isolates, soy extracts used in pharmacological doses and large amounts of hidden soy in a processed food diet.

Food additive references

The evidence for and against food additives is probably the most contentious I have ever assessed, second only to vaccinations. They both are highly emotive.

The official (and this includes government and dieticians) line is that all additives that have been sanctioned for use in this country are safe (within a specified dosage range), though a few individuals have demonstrable allergies – they are the minority.

But some scientific (see clickable guide below) and certainly a lot of anecdotal evidence, seems to suggest otherwise.

Some aspects of the additive saga that have not been adequately investigated include the synergistic and cumulative effects of a wide variety of chemicals added to the diet, overall dosage of these different additives and environmental issues that may be causing us to be more intolerant/allergic individuals.

Additives generally considered safe:
Colours
101 (B2)
160(a) (betacarotene, Vitamin A)

Antioxidants
300-304 (types of Vitamin C)
306-309 (types of Vitamin E)

Emulsifier
322 (lecithin)

Stabilizers
375 (niacin)
40 (pectin)

In an allergic individual (prone to rashes, asthma, eczema, hayfever etc) treat all other additives with suspicion.

If you experience mood changes or suspect your child of having ADHD or learning difficulties – an unrefined diet will have the added benefit of being nutrient rich, regardless if the jury is still out on the role additives play in these conditions.

References

A clickable reference guide to each additive, linking to abstracts from medical databases

Food Intolerance Network - Sue Dengate (mother and author of books on food intolerances). Check out the Nasty Foods awards.

Top 20 additives to avoid and also the handful that are ok to eat.

MBM additive guide

update: check out a further post on additives in infant medicines