Child cold medicines don't work: FDA advisors

Tegan Fleming

The recommendation follows the voluntary withdrawal of several brands of cough and cold medicine for children under two years of age earlier this month.

The FDA’s joint advisory committee said the over-the-counter medicines should be studied further to determine efficacy, despite their long history of use.

"The data that we have now is they don’t seem to work," said Sean Henry, a University of Pennsylvania epidemiologist and one of the FDA experts gathered to examine the medicines.

Linda Suydam, president of the Consumer Healthcare Products Authority (CHPA) said the medicines are safe when used as directed.

"Harm to this age group, while very rare, is attributable in most cases to accidental ingestion – an issue of safekeeping that is best addressed through education.

"Today, the advisory committee decided that there was insufficient evidence in paediatric populations to support efficacy. This is an issue we will address with the FDA.

"We are already planning pharmacokinetic studies in children, which are the first step toward confirming correct dosing, and we will work with the FDA to design appropriate paediatric clinical efficacy studies," Ms Suydam said.

Australian experts have said the Schedule 3 status of the medicines in Australia makes similar action here unnecessary.