Australian INFANTS COUGH and COLD remedies become prescription only

THE CASE
On 9/04/2008 The national Drugs and Poisons Scheduling Committee announced that all infant cough and cold preparations would be prescription only.

See "TGA announcement regarding the use of cough and cold medicines in children".

This is the correct decision but pharmacists and parents with young children won't be pleased.


THE BACKGROUND

In September 2007 the US Food and Drug Administration (FDA) announced that it was considering a ban on cough and cold medicines targeted for all children under six years. This was in response to a retrospective investigation, going back nearly 40 years, of 54 deaths associated with the ingredients pseudephedrine, phenylephrine and ephedrine. There were a further 69 deaths associated with preparations containing the antihistamines diphenhydramine, brompheniramine and chlorpheniramine. Not many deaths, admittedly, but it does indicate a pattern.

One month later in October 2007 an independent expert group advised the FDA to ban the sale of over the counter cough and cold medicines for use in infants under two years old. A majority of these experts also advised the FDA to ban the sales for all children under six.

The FDA has yet to make a final decision, but some of the more responsible drug companies such as Wyeth, and some pharmacy chains have stopped marketing them already. Medicines voluntarily withdrawn in the USA include brands commonly sold in Australia, for example some of the Dimetapp range and some of the Robitussin range.

STOP PRESS

In an extraordinary example of parallel thought, (?????) the Sydney Morning Herald (SMH) published an article on the same topic just a day and a half after I posted my original one. See "Cough syrup risk alert"

This article presented the TGA view that as these medicines are more tightly controlled in Australia, there is less risk. Sales must be personally supervised by a pharmacist. Fair enough, but decisions must be made on the basis of the evidence of the presence or absence of actual harm.

Professor Colin Robertson, director of respiratory medicine at the Royal Children's Hospital in Melbourne, said the drug regulator was "dodging the issue" and urged it to follow the lead of the FDA.

This doesn't address evidence based medicine either, it is just opinion.

MY VERDICT

In this series of articles I have highlighted a number of cases where the TGA has been slow or neglectful, such as with the anti-smoking drug varenicline with biphosphonate associated jaw osteonecrosis and even with the zolpidem pack sizes.

What bothers me about the TGA is its inertia. A statement about the issue, directed to pharmacists and other health care workers, should have been made months ago. But now they have made a good decision.


FURTHER READING

Cough and Cold Products for Children: Risk and No Benefit

http://sciencebasedpharmacy.wordpress.com/2009/05/19/cough-and-cold-products-for-children/