Parents will be told that over-the-counter cough and cold medicines do not work on children under 12 and can even cause side effects like hallucinations under shock new advice issued.
A review of popular remedies such as Lemsip powders, Day Nurse and Sudafed by the Medicines and Healthcare products Regulatory Agency (MHRA) found "no robust evidence that these medicines work" in children.
The MHRA added that the possible side effects — although not dangerous — could include sleep disturbance, allergic reactions and hallucinations.
In the face of the lack of evidence that the medicines do any good they have decided that many can no longer be sold for use on children under six.
New, clearer advice will be published on packets for dosage of children between six and 12 and more research is being done to see what benefits, if any, the medicines have.
Pharmacists will be issued with new advice to give to parents about which medicines can be used safely.
But the MHRA said that parents should not worry if they have used the medicines in the past and shop shelves will not be cleared of current stocks.
Pain relief preparations and remedies used to lower a child’s temperature, such as Calpol, are unaffected by the new rules.
For children under six the MHRA recommends that parents stick to simple remedies like keeping their child’s temperature down and simple honey and lemon mixtures to ease a cough.
MHRA spokesman Jeremy Mean explained that children’s physiology differs from adults so that remedies proven to work on an older body cannot be assumed to have the same effect on youngsters.
He said that all children’s medicines were being reviewed due to a "change in thinking".
"Many years ago it was thought that we could use adult doses in a watered down way but we now know that children’s bodies are different."
But the MHRA have identified a list of eight medicines that do work and are safe to use on children under six.
They include Beechams Veno’s Honey and Lemon, Benylin Tickly Coughs and CalCough TicklyCare Glycerin Lemon & Honey with Glucose although none should be given to babies under one year old.
Director of Vigilance and Risk Management of Medicines at the MHRA, Dr June Raine, said: "Coughs and colds can be distressing for both you and your child but they will get better by themselves within a few days. Using simple measures to ease symptoms is likely to be most effective.
"Over-the-counter medicines used to treat coughs and colds have been used for many years. However they came into use when clinical trials were not required to demonstrate that they worked in children. This means they were not specially designed for children.
"It is not right to assume safety and efficacy based on children being ’small adults’. Children should have access to medicines that are acceptably safe and designed for their use."
The trade body for over-the-counter medicine manufacturers, the Proprietary Association of Great Britain (PAGB), said that the affected remedies would no longer be marketed for children.
Sheila Kelly, PAGB executive director said: "PAGB and its member companies continue to have confidence in the value that these medicines have in the management of children’s coughs and colds for children over six years. Products continue to be available for this older age group and manufacturers are committed to developing the robust evidence base that is now required. A clinical research programme has already begun in the United States."
High street pharmacy Boots said: "Following a review by the healthcare products regulatory agency it has announced that it will be putting measures in place to promote the safe use of over-the-counter cough and cold medicines for children under 12 years old.
"As the owner of Boots branded medicines and as a responsible retailer, we will be following the MHRA guidance.
"Any customers using these products for children, or who have used them in the past, do not need to worry. If you have any concerns or questions then speak to your Boots pharmacist for advice."
Pharmaceutical giants have let mums down
Helen Carson, the mother of a young son, says parents who bought cough medicines will be left worried by fears over side-effects
The news about the ineffectiveness of some children's medicines will be a bitter pill to swallow for parents.
And some of the biggest brand names in over the counter medicine have been implicated in the latest announcement by the Medicines and Healthcare products Regulatory Agency (MHRA) findings.
Names such as Benylin and Tixylix, which are synonymous with children's health and indeed are the first thing a parent reaches for when their child is unwell, may not work at all with young children. And to add insult to injury they may even cause nasty side effects such as allergic reactions or even hallucinations.
As a mum of a nine-year-old boy, I have spent most of my son's life treating him with many of these medicines, and I chose them because I they were tried and trusted names, big brands subjected to rigorous testing and trials to ensure both their safety and efficacy.
Now, even a cursory look in my medicine cabinet shows nothing that is now considered of any value should my child develop the sniffles.
The companies which have manufactured and marketed these ‘medicines' at up to £3 a bottle have been coining it in at my — and many other parents’ — expense.
It appears all I needed was to pop down to the supermarket and buy a lemon to go with the honey in my cupboard and this old-fashioned cure-all would have done the same thing — for a fraction of the cost.
Maybe, as the MHRA has suggested, it’s time for some traditions to have a renaissance, such as medicines being safely and prudently dispensed by a pharmacist who has studied diligently for years to dispense medicines, and can easily point out side-effects and possible clashes with other medication or conditions. And if the companies which have profited from medicine sales plough some of that money back into essential research and development, then we'll all feel a whole lot better.
Here are the medicines that the MHRA have said there is “no robust evidence” on whether they work on children under 12. Labels on the remedies in the second group will now be changed to indicate they cannot be given to children under six. But the MRHA have said that parents are still safe to give all the medicines listed to children over the age of six, if they feel they will benefit.
Medicines not currently labelled with doses for under sixes
Allens Pine and Honey Balsam
Beechams Decongestant Plus with Paracetamol
Beechams Flu Plus
Benilyn Chesty Coughs (Original and Non Drowsy)
Benilyn Dry Coughs (Original and Non Drowsy)
Benylin 4 Flu
Benylin Cold & Flu Max strength
Benylin Cough and Congestion
Benylin Dual Action Night Cough & CongestionCare
Covonia Original Bronchial Balsam
Lemsip Max Cold & Flu, Day & Night Cold & Flu relief, Daytime Cold & Flu relief
Lemsip Max Sinus Capsules (Non- Drowsy)
Sudafed Congestion & Headache Capsules (Non-Drowsy)
Sudafed Congestion Cold and Flu (Non-Drowsy)
Sudafed Dual Relief
Otrivine Antistin Eye Drops
Robitussin Dry Cough Medicine
Tixylix Dry Cough
Vicks Cold & Flu Care Daymed Capsules
Vicks Cold & Flu Care Medinite Complete Syrup
Vicks Sinex Decongestant Nasal
l Vicks Sinex Micromist
Vicks Sinex Soother
Medicines currently labelled with doses for under sixes
Beechams Veno’s Expectorant
Beechams Veno’s Honey & Lemon
Benilyn Childrens Chesty Coughs
Benilyn Childrens Coughs and Colds
Benilyn Childrens Night Coughs
Benylin Children’s Dry Cough
Care Glycerin lemon & honey with Ipecac
Family Meltus Chesty Coughs Honey and Lemon Flavour
Galenphol Paediatric Linctus
Meltus Chesty Coughs with Catarrh
Junior Meltus Dry Coughs with Congestion
Junior Meltus Dry Coughs with Congestion
Lemsip Cough and Cold Chesty Cough Medicine
Lemsip Cough Chesty
Medised for Children
Multi-Action Actifed Chesty Coughs
Mutli-Action Actifed Dry Coughs
Non- Drowsy Sudafed Childrens
Non Drowsy Sudafed Expectorant
Non Drowsy Sudafed Linctus
Otrivine Childrens Nasal Drops
Robitussin Chesty Cough Medicine
Robitussin Chesty Cough with Congestion
Tixilix Cough and Cold
Tixylix Chesty Cough
Tixylix Night Cough
Vicks Cough Syrup for Chesty Coughs
Vicks Cough Syrup for Dry Coughs
Medicines recommended for children under six
- Baby Meltus Cough Linctus
- Beechams Veno’s Honey and Lemon (Not to be given under one year)
- Benylin Children’s Tickly Coughs (Not to be given under 3 months)
- Benylin Tickly Coughs (Non drowsy) (Not to be given under one year)
- CalCough TicklyCare Glycerin Lemon & Honey with Glucose (Not recommended under one year.)
- Lemsip Cough Dry Tixylix Baby Syrup (Not recommended under 3 months)