Parents need to carefully read the labels on all over-the-counter medicines and dietary supplements for children. In this report by SADE OGUNTOLA, experts warn that some liquid medicines for children contain excipients that are potentially dangerous to them.
W HEN it comes to giving children medicines, the risks are high because even the smallest mistake could be tragic. Children are not just small adults, and they need medications that have been specifically designed for their size and their needs.
Aside from fever and pain medicines, few over-the-counter products have actually been studied in children for effectiveness, safety or proper dosing.
Medication safety with children could be challenging because irritable, sick children often do not like to take medicine, while on the other hand, some can develop serious side effects.
For instance, an iron and vitamin supplement led to seizures in a young girl due to its high alcohol content. The child began having seizures while taking a shower. The family immediately called for help.
All scans and x-rays were negative. Doctors then ordered blood tests on the child. It was found that the child had an elevated blood alcohol level. This was most likely the cause of the child’s symptoms
Tonic is an over-the-counter high potency liquid iron/B vitamin supplement. This product contains 12 per cent alcohol, which is equivalent to a 24 proof beverage. The child was only took the supplement for a few days and took the correct, recommended daily dose.
Typically, giving these products at the recommended doses is safe and not a cause for alarm. But, some children may not be able to tolerate even small amount of alcohol in such products.
All forms of medicine contains ingredients as well as the drug – these are called excipients. Excipients don’t have any medical effect but they are needed for a variety of reasons; to improve the taste, texture, dissolve the medicine, make them work better or last longer. They have however been reported to trigger safety issues.
Ironically, in 2015, two-thirds of newborns in 21 European countries who received common medicines were deemed to have been exposed to at least one potentially dangerous excipient in their medication, out of the eight examined.
Unfortunately, Nigeria’s baby medications also contain potentially harmful additives such as ethanol and sucrose. A survey of community pharmacies found many children’s liquid medicines tested, contain quite high amounts of ethanol and other potentially harmful excipients.
To dissolve the medicine – small amounts of ethanol (alcohol) may be used to help a drug dissolve to make a liquid medicine.
There was a survey of children’s medications offered for sale in registered pharmacies in South Eastern Nigeria over a two month period in line with international labelling guidelines and allowable daily limits (ADL). Of course, drugs in this region could be a representative of those in other parts of the country.
These are medicines used for a wide range of health problems, including pain, heartburn, diarrhoea, malaria, antibiotics, cough/cold/flu medicines, and vitamin supplements.
Those with accessible information leaflets were assessed for the presence and quantity of excipients with potentials to harm children they contain.
Of the 380 liquid medicines for children, 140 provided access to list/quantity of ingredients. Protective screw caps, warning instructions, concentration in mg per dose were absent in many.
About 47.9 per cent (67) of the formulations contain at least one of the excipients that might be potentially harmful in children while the remaining only listed the active ingredients.
Ethanol had the highest occurrence (62.7 per cent) and was more in cough/cold medicines. A homoeopathic cough and cold remedy contained 90 per cent alcohol.
Ethanol and sucrose in some of these liquid children’s medicines exceeded the concentrations approved daily intake (ADI) (1–90% v/v and 1.7 g–3.7 g/5 ml respectively). Sucrose a natural sweetener ranked second with 11 (16per cent) and combination of sweeteners in 27 (40 per cent) formulations.
Aside from their quite high ethanol content, the survey found that ethanol-containing formulations were prescribed for children below 6 years and older. Only 26 (38.8 per cent) completely satisfied the labelling requirements for ethanol containing formulations.
The findings of the survey were published in the 2019 journal, BMC Research Notes. It involved Rebecca Soremekun, Irene Ogbuefi and Roseline Aderemi-Williams at the Department of Clinical Pharmacy, Faculty of Pharmacy, University of Lagos.
Excipients previously named as having the potential to harm children include ethanol, propylene glycol, sorbitol, saccharin sodium, aspartame, parabens, sodium benzoates, polysorbate 80 and the azo dyes.
Dr Soremekun, lead of the study, declared that the excipients that were predominant were ethanol and sugar which were not healthy for children. They stand a higher risk of both acute and chronic alcohol-related toxicities.
According to her, what developed countries such as the USA and UK did was to shift away from formulations that contain excipients that were potentially dangerous for children.
“What they are making now are sugar-free children tablet that you can disperse in water and give them,” she added.
Soremekun, a pharmacist lecturer at the University of Lagos, said because there was a limit to which a child could metabolise ethanol, rather than paracetamol tincture, babies now have paracetamol that is free of ethanol.
Dr Soremekun added, “What we are trying to say is if pharmacokinetically we see that some excipients could cause some harm to children, let us begin to change them. Medicines anywhere in Nigeria are the same; they are made by the same people and distributed all over.”
She said further studies are on to try to see whether some side effects seen in some children being managed by doctors in children’s clinics are because of these excipients in liquid medicines for children.
“And gradually, policymakers should be able to come out to say do not make products with this excipients anymore because they are causing some unwanted effects on children,” she added.
That many excipients are not even stated in children medicines and other products made in Nigeria, unlike many other imported ones, she said also need to be reviewed by NAFDAC.
According to her, “many local drug manufacturers take excipients as their propriety right or trade secret, and therefore neither declare their names nor concentration on the labels and inserts. But in the UK and USA, it is not so. You are required to state it.”
The World Health Organization (WHO) proposed a limit for the ethanol content in OTC products to less than 0.5% for children less than six years old, less than 5 per cent for children between 6 and 12 years old and less than 10 per cent for children over 12 years.
This WHO’s guideline is not being utilised in the regulation of oral liquid pediatric formulations in Nigeria.
The high level of ethanol usage in Nigeria did not even take into consideration the possibility of accidental intake by children of all ages, the speed of metabolism and the distribution volume in children.
Dr Akinlolu Adepoju, a consultant peadiatricain, University College Hospital (UCH), Ibadan, however assured that local drug manufacturers in Nigeria know that excess alcohol in medications could damage the liver in children.
According to him, “it is only in adults that we have seen alcohol consumption as a problem for the liver because people abuse it. But for a child, even if paracetamol has alcohol in it and the child takes it two to three days that is not going to be a problem.”
Dr Bayo Akinosun, a consultant chemical pathologist, UCH, Ibadan, however, declared that no amount of alcohol is safe in any age group.
He declared, “alcohol is not good for all ages, we do not encourage them to take alcohol.”
The French Medicines Agency had banned the use of ethanol in medicinal products intended for children unless absolutely necessary and if used, the amount should not produce blood concentration greater than 0.125 g/l.