Withdrawal unnecessary: experts

Tegan Fleming

Earlier this month, the US Consumer Healthcare Products Association (CHPA) announced the voluntary withdrawal of cough and cold medicines for infants aged two years and under.

Linda Suydam, CHPA president, said "rare patterns of misuse leading to overdose" led to the withdrawal, adding "It's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately. These voluntary actions are being taken out of an abundance of caution."

The Therapeutic Goods Administration (TGA) recently conducted a review looking for any pattern of adverse events associated with cough and cold medications in children and found "no evidence of significant adverse events in Australia", a spokeswoman said.

A spokesman for Wyeth, maker of Dimetapp and Robitussin infant cough and cold products, said the company was talking with the TGA but had no plans to withdraw any of its products in Australia.

The US Food and Drug Administration is currently evaluating the issue at a meeting -- and Australian Self-Medication Industry scientific director, Deon Schoombie, predicted Australian drug companies would wait for its outcome before acting.

"We have not received any advice from any of our members intending to withdraw product, but that doesn't mean it's not going to happen, so it will be individual company decisions in the end," Mr Schoombie said. "I think the evidence suggests that if the products are used strictly according to the label instructions, there are no risks or problems associated with it. The risks or adverse reactions have been reported in relation to misuse or overuse.

"The regulatory system in Australia differs significantly [from the US] in one particular aspect, in that we've got a Schedule 3, a pharmacist-only schedule, which requires intervention by a pharmacist."

He said the products in question were all scheduled S3, providing a safety net unavailable in the US.

Pharmacy Self Care principal adviser, John Bell, agreed that regulatory differences between the countries made all the difference to safety.

"I think the significant difference here is that we have pharmacy-only and pharmacist-only categories of medicines, which they don't have in the US. So I think the circumstances are a little bit different here -- and to my knowledge, we haven't had similar reports of overdose occurring.

"Whether the decision that's been taken in America by the manufacturers themselves will have implications here, we don't quite know that yet," he said.

Adverse Medicine Events Line day-to-day manager, Geraldine Moses, said the consumer telephone hotline had not received any reports of adverse reactions to infant cough and cold medicines.

Ms Moses also agreed that Schedule 3 made the Australian situation different from that in the US.

"We don't have any evidence to say that the products we have here [in Australia] are causing any problems.

"If we think it's going to be inappropriate for an infant then luckily we've got S3 to ensure that the pharmacist intervenes," she said.