Tighter restrictions planned for kids’ cough meds
AUSTRALIAN regulatory authorities are recommending that cough and cold medicines should not be used in children younger than six years.
New TGA proposals advise that over-the-counter (OTC) cough and cold preparations are not recommended for under-6s and should only be given to six- to 12-year-olds on the advice of a doctor or pharmacist.
The advice follows a safety and efficacy review of antihistamines, antitussives, expectorants and decongestants in children and, if implemented, would bring Australia into line with advice in the UK, US and Canada.
In a public consultation document, the TGA said reviews showed the available clinical data did not provide evidence of efficacy of these medicines “and their use is not without attendant risks”.
However, a TGA internal panel report showed that cough and cold preparations had a “relatively safe” history. Only 99 adverse reactions had been reported since 1981 in children aged 12 years or younger, including 14 serious reactions.
The panel recommended that the National Drug and Poisons Schedule Committee be asked to consider cough and cold ingredients used for children younger than six years be upscheduled to S4, and to S3 for children aged six-12 years.
Paediatric specialists have welcomed the move, which follows the previous upscheduling of cough medicines for children younger than two years of age, saying the preparations were of no proven benefit at any age.
Paediatric respiratory physician Associate Professor Dominic Fitzgerald, from the Children’s Hospital at Westmead, said it was “to the TGA’s credit” that it was acting to restrict the use of medications that had no proven benefit.
In children younger than two years of age, the danger of cough medicine ingredients was sedation and overdose, he said. But in two- to six-year-olds the concern was inappropriate dosing and missed diagnoses of conditions such as asthma or bacterial bronchitis because a GP had not been consulted, he added.
“If you want something that [soothes], give honey on a teaspoon,” he said.
Clinical pharmacologist Associate Professor Noel Cranswick, from the Royal Children’s Hospital, Melbourne, said Cochrane reviews found that drug treatment was no more effective than placebo for acute cough in children.