Just how safe for children are ‘over the counter’ medications?

Generally over the counter (OTC) medications for children are used to treat fevers, upper respiratory tract infections, coughs, colds and diarrhoea. They are non-prescription preparations that are commonly purchased at a pharmacy or supermarket, and include paracetamol, antihistamines and cough, cold and flu preparations.

Because OTC medications are readily available, it is often assumed by parents that they are safe. However, childhood unintentional poisoning by pharmaceuticals ranks second only to falls as a cause of hospitalisation in the 0-4 years age group (MUARC 2002). The number of hospitalisations due to paracetamol poisoning has also significantly increased.

There is evidence to say that we are medicating our children more than we have in the past. A study of the Queensland University of Technology found that compared to the 1980’s where 67% of parents used medications to manage a child’s fever, by 2006 that figure was 95%. Another survey of primary school children conducted in 2006 found that 60% had used at least one medication in the two weeks before the survey. In 70% of cases this involved over the counter medicines, mainly paracetamol, cough and cold preparations and vitamins.

One reason why there has been a note of caution sounded by medical practitioners in recent times is that there have been few clinical trials conducted on people under the age of 18. Child formulations are worked out on what is appropriate for an adult and then calculating an appropriate dosage based on a child’s average weight for age. Gerry Silk, author of Caring for Sick Children, a basic guide points out that that children are not small adults – they differ in their anatomy, physiology and in the way they react to illness.

For example:

• the airways are much smaller in children than in adults
• children have higher pulse rates, breathing rates and metabolic rates
• fluid is lost more easily from a child than an adult and they can therefore become dehydrated more rapidly
• children who are unusually quiet may be very unwell and require immediate attention
• children become sick quickly, but also get better very quickly

These kinds of differences can mean that children don’t process drugs in the same way. A medication suitable for an adult may not work in a child or have dangerous side effects.

Common mistakes in dosage

When a child first shows signs of illness; flushed or hot face, a raised temperature, runny nose and maybe a developing cough, paracetamol is frequently the first line of treatment, and given to reduce a child’s temperature.

Paracetamol is considered a safe medication to give children, but there are more than 100 products available which contain paracetamol, with many brands for children which vary widely in type and strength.

Health professionals consider that the main risk is in its overuse in the treatments of fevers, with some possible danger to the liver.  Silk notes that because they have faster metabolic rates, children’s temperatures can rise at the end of a day, especially if they have been active. Don’t panic or automatically reach for the paracetamol if your child has a temperature of 38C at 6pm. The wise parent will always base any decision on their child’s behaviour – alert and active (no need to worry) or passive and lethargic (a bad sign).

The most important thing to avoid over dosing is to realise that the recommended dosages for children are based on weight, not age. Over weight children in particular can be at risk here, because while their body weight may be heavier than average for their age, their liver is not. Silk recommends as a rule of thumb, that if a child is heavier than average for their age, give paracetamol based on their age (ie a smaller dose), otherwise use a child’s weight as a guide.

Sometimes as a child develops a cough or cold, they may be given a cough or flu medication which also contains paracetamol – parents in effect may be unknowingly double-dosing their child.

Ibuprofen is a non-steroidal anti-inflammatory agent and it is useful in easing the symptoms of certain childhood minor ailments. While the overall safety of paracetamol and ibuprofen is similar, ibuprofen is associated with an increased risk of gastro/intestinal bleeding and it can worsen asthma in susceptible children.

Common errors here include double-dosing a child with paracetamol and ibuprofen, or giving ibuprofen at four hourly intervals instead of the recommended six or eight hours.

Children should never be given any OTC medication for more than 48 hours without being assessed by a doctor. Paracetamol should only be used sparingly to relieve discomfort in mild short-term illnesses.

Other precautions

• Aspirin should never be given to children because of a strong association with Reye’s syndrome in children under 15.
• Rehydrating fluids like Pedialyte can be used in the treatment of any gastroenteritis (diarrhoea). While very useful, they must be prepared correctly and instructions followed in detail to avoid the solution becoming over-concentrated.
• Oral decongestants are generally not helpful for children under 12 because of potential side affects and should not be used by children under the age of two years.
• Nasal sprays are not recommended for babies and children because they can cause rebound congestion (meaning as soon as you stop using them the congestion will return). An exception is a saline spray such as Fess which is simply a mild salty water solution which flushes out the nose.
• Avoid accidental overdose - while over the counter medications are much less likely to result in accidental overdose than prescription medicines, all medications should be stored safety in a childproof cupboard out of reach. Don’t rely on the child resistant lids to keep your child safe.

A special word on antihistamines

Some antihistamines contain an active ingredient know as promethazine (Phenergan, Avomine) or appear in combination (Painstop, Tixylix, Phensedyl). Alarmingly, a survey of mothers’ groups quoted in Australian Doctor indicated a trend towards using such antihistamines as a sedative for younger children. In 1-3 percent of children the opposite effect can occur, with the child becoming extremely agitated and distressed. These products also warn against use in under-twos because of a link with SIDS.

When to see the doctor

See the doctor if the child:

• Refuses to drink fluids
• Vomits frequently
• Complains of intense headache
• Is pale and sleepy
• Has difficulty breathing
• Has a high fever that does not respond to paracetamol
• Does not improve in 48 hours
• Causes parents to worry.

References

Care for Sick Children: a basic guide. Gerry Silk. Ausmead Publications 2006

Use of over the counter and complementary medicine in children. Dr Noel Cranswick. Australian Doctor, July 2006. Royal Children’s Hospital, Melbourne.

Over the counter medication use for childhood fever: a cross-sectional study of Australian parents. Anne Walsh, Helen Edwards and Jenny Fraser. 2007. Institute of Health and Biomedical Innovation, QUT.

Monash University Accident Research Unit (MUARC) 

This article was first published by Australian Family Magazine, October 2007. Updated July 2009.