Parents 'should not give children over-the-counter cough medicines'

The Medicines and Healthcare products Regulatory Agency (MHRA) found "no robust evidence that these medicines work" in children and added that the possible side effects could include sleep disturbance, allergic reactions and hallucinations.

Clinical trials have traditionally not been required to demonstrate that products are effective treatments for children. The agency said this thinking was changing.

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.

The MHRA said parents should not worry if they have used the medicines in the past, and shop shelves will not be cleared of current stocks.

Popular pain relief preparations and remedies used to lower a child's temperature, such as Calpol, are unaffected by the new rules.

Eight medicines that do work and are safe to give to children under six include Beechams Veno's Honey and Lemon, Benylin Tickly Coughs and CalCough TicklyCare Glycerin Lemon and Honey with Glucose, although none should be given to babies under a year old.

The Proprietary Association of Great Britain, the UK body representing manufacturers of over-the-counter medicines and food supplements, said it was supporting the new guidance, and that a million advice leaflets would be sent to all British pharmacies in the next few days to help parents.

But with so many household names on the "to avoid" list, the advice could cost global pharmaceutical companies millions of pounds as parents abandon leading brands.

One parent determined not to use cough and cold medicines following the new rules is Gaynor Thomson, mother of a six-year-old daughter, Rachel.

The 40-year-old Edinburgh midwife said she had come to her own conclusions about the lack of effectiveness of many popular medicines, but said the advice reinforced her decision that Rachel would not be given any again.

She said: "I've got a number of bottles in the cupboard but am more likely to use something with paracetemol like Calpol.

"But this would be the end of many medicines as far as I'm concerned.

"You don't know what children will react to, so the fact that kids can have allergic reactions to some on the list is enough to put many parents off."

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 said that children's physiology differed from that of adults and therefore remedies proven to work on older patients could not be assumed to have the same effect on youngsters.

He said: "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."

Dr June Raine, director of vigilance and risk management of medicines at the MHRA, added: "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."

Sheila Kelly, Proprietary Association of Great Britain executive director said: "We and our 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."

Boots added: "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."

Basic remedies on the list Here are the medicines of which the MHRA has said there is "no robust evidence" on whether they work on children under 12.

Labels on the remedies in the second group will be changed to indicate they cannot be given to children under six.

But the MHRA has said it is still safe to give all the medicines listed to children over the age of six, if parents feel they will benefit.

Medicines not labelled with doses for under-6s Afrazine Nasal Allens Pine and Honey Balsam Beechams Decongestant Plus with Paracetamol Beechams Flu Plus Beechams Powders Benylin Chesty Coughs (Non Drowsy) Benylin Chesty Coughs (Original) Benylin Dry Coughs (Non Drowsy) Benylin Dry Coughs (Original) Benylin 4 Flu Benylin 4 Flu Benylin Cold & Flu Max strength Benylin Cough and Congestion Benylin Dual Action Night Cough & CongestionCare Pholcodine linctus Covonia Original Bronchial Balsam Day Nurse Fenox Nasal Lemsip Max Cold & Flu Lemsip Max Day & Night Cold & Flu relief Lemsip Max Daytime Cold & Flu relief Lemsip Max Sinus CapsulesNon- Drowsy SinutabNon-Drowsy Sudafed Congestion & Headache Capsules Non-Drowsy Sudafed Congestion Cold and Flu Non-Drowsy Sudafed Dual Relief Otrivine Antistin Eye Drops Otrivine Mucron Robitussin Dry Cough Medicine Tixylix Dry Cough Vicks Cold & Flu Care Daymed Capsules Vicks Cold & Flu Care Medinite Complete Syrup Vicks Sinex Decongestant Nasal Vicks Sinex Micromist Vicks Sinex Soother Medicines labelled with doses for under-6s Beechams Veno's Expectorant Beechams Veno's Honey & Lemon Benylin Children's Chesty Coughs Calcough Chesty Benylin Children's Coughs and Colds Benylin Children's Night Coughs Benylin Children's Dry Cough Calcold Calpol Night Care Glycerin lemon & honey with Ipecac Cofsed Linctus Family Meltus Chesty Coughs Honey and Lemon Flavour Galenphol Linctus Galenphol Paediatric Linctus Galpseud linctus GalsudJunior 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 Multi-Action Actifed Chesty Coughs Mutli-Action Actifed Dry Coughs Non- Drowsy Sudafed Children's Non Drowsy Sudafed Expectorant Non Drowsy Sudafed Linctus Otrivine Children's 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

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