Over-the-counter sale of child cough medicine for young children to be banned

Apr 9 2008

As from September this year the over-the-counter sale of cough medicines for children under the age of two years old will be banned in Australia.

The decision of a Federal Government committee to reschedule the drugs means they will in future only be available with a prescription.

This action by the National Drugs and Poisons Scheduling Committee (NDPSC) follows similar bans in the U.S. and UK after a number of reports of side-effects and accidental overdoses.

The Committee has found that safety concerns surrounding the use of these medicines outweighed the benefit from providing them over the counter and is concerned that parents might be using the drugs to sedate children.

The Australian Medical Association says the ban is a good precaution and caution should also be used using the products with children over the age of two.

The ban will affect many popular cough and cold medicines and means 15 products will be taken off the shelves of pharmacies and rescheduled as prescription medicines.

The ruling follows reports of adverse reactions to sedating antihistamines in the products in Australia, including agitation, insomnia, hallucinations and over-sedation and reports from the UK of serious reactions, including convulsions, rapid heartbeat and death.

Pharmacists and doctors will be informed in writing by the TGA that these medicines are no longer suitable for children under two years of age unless specifically prescribed by a doctor and to label them accordingly.

Experts have welcomed the decision and some say the products should be banned for all children as recent research has also shown that such products offer little benefit.

The TGA advises parents and health care professionals not to give cough or cold medicines containing sedating antihistamines to children under two years of age.

The TGA says for children two years of age and over the instructions on the medicine label must be read and followed and the recommended dose, frequency of dose or the recommended duration for use, must be adhered to.

Only a medicine measuring spoon or medicine measure supplied with the product or obtained from a pharmacy should be used to measure the dose.

The TGA also warns about giving a child additional medicines containing these ingredients at the same time unless a pharmacist or doctor has given such specific advice.

The medicines affected are:-

• AUST R 119323 AMCAL Infant Decongestant and Antihistamine Drops
• AUST R 71492 Chemists Own Infants Cold and Allergy Drops 1 Month to 6 Years
• AUST R 63198 Demazin Cold Relief Colour Free Syrup Infant Drops
• AUST R 116393 Demazin Cold Relief Blue Syrup Infant Drops
• AUST R 59769 Dimetapp Colour Free Infant Drops
• AUST R 43578 Dimetapp DM Cold and Cough Paediatric Drops
• AUST R 60799 Dimetapp DM Colour Free Paediatric Drops
• AUST R 59768 Dimetapp Infant Drops
• AUST R 20862 Paedamin Decongestant & Antihistamine Syrup for Infants and Children
• AUST R 146136 Priceline Congested Cold and Cough Paediatric Drops
• AUST R 63361 Pharmacist Cold and Allergy Infant Drops with Dropper
• AUST R 92446 Pharmacist Cold and Allergy Paediatric Drops
• AUST R 94150 Pharmacy Health Cold and Cough Paediatric Drops
• AUST R 81817 Soul Pattinson Congested Cold and Cough Paediatric Drops
• AUST R 63546 Soul Pattinson Infant Decongestant and Antihistamine Elixir

The TGA says any concern about the directions for use or difficulty in understanding the instructions on the medicine label can be resolved by speaking to a pharmacist or doctor.

The 'Record of Reasons' fully outlining the reasons for the NDPSC's decision regarding this matter is available on the TGA website.