Sunday, March 01, 2009

Warning over cough medicines for children

Taken from Yahoo News, 01/03/09 (via ITN news)

Over-the-counter cough and cold medicines do not work on children under 12 and can even cause side effects, a review has found.

The Medicines and Healthcare products Regulatory Agency (MHRA) found "no robust evidence" that popular remedies such as Lemsip powders, Day Nurse and Sudafed work when given to youngsters.

The MHRA added that the possible side effects - although not dangerous - could include sleep disturbance, allergic reactions and hallucinations.

Many can no longer be sold for use on children under six and pharmacists will be issued with new advice to give to parents about which medicines can be used safely.

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 parents stick to simple remedies like keeping their child's temperature down and simple honey and lemon mixtures to ease a cough.

However, the agency 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.

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 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.

The following is a list of medicines which the MHRA says there is "no robust evidence" on whether they work.

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

The MHRA says it is still safe to give all the medicines listed to children over the age of six, if they feel they will benefit.

* Medicines which can be given to under sixes *
Baby Meltus Cough Linctus
Beechams Veno's Honey and Lemon (not to be given under 12 months)
Benylin Children's Tickly Coughs (not to be given under three months)
Benylin Tickly Coughs (non-drowsy) (not to be given under 12 months)
CalCough Tickly
Care Glycerin Lemon & Honey with Glucose (not to be given under 12 months)
Lemsip Cough Dry
Tixylix Baby Syrup (not to be given under three months)
Pain relief products such as Calpol are not affected by the new advice

* Medicines whose current labelling will be changed under the new guidance *
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
Calcough Chesty
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
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 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 not currently labelled with doses for under sixes and therefore should not be given *
Afrazine Nasal
Allens Pine and Honey Balsam
Beechams Decongestant Plus with Paracetamol
Beechams Flu Plus
Beechams Powders
Benilyn Chesty Coughs (Non-Drowsy)
Benilyn Chesty Coughs (Original)
Benilyn Dry Coughs (Non-Drowsy)
Benilyn Dry Coughs (Original)
Benylin 4 Flu
Benylin 4 Flu
Benylin Cold & Flu Max strength
Benylin Cough and Congestion
Benylin Dual Action Night Cough & Congestion Care
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 Capsules Non-Drowsy
Sinutab Non-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

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