The US Food and Drug Administration has issued an alert recommending that over-the-counter cough and cold medicines should not be given to children aged under two, because of “serious and potentially life-threatening side effects”.

According to the agency, it has uncovered a “wide variety” of rare but serious effects from the use of products such as - decongestants, expectorants, antihistamines and cough suppressants - in this age group, including death, convulsions, rapid heart rates and decreased levels of consciousness.

“These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under two,” explained Charles Ganley, director of the FDA's Office of Nonprescription Products. The agency's review of data for two-to-11-year-olds is still ongoing.

Wyeth Consumer Healthcare has come out in support of the FDA’s decision, which, its president Cavan Redmond says, “is consistent with our voluntary removal in October 2007 of OTC infant cough and cold products from the global market to help reduce dosing errors and overdoses in children who are most vulnerable to misuse of these medicines”.

Paediatric testing
And the move further underscores the urgent need to increase the clinical testing of medicines in children to ensure that their safe use, as currently being addressed by the World Health Organisation.

Towards the end of last year, the WHO launched its global Make Medicines Childsize campaign, which is designed to help plug the significant gap between the availability of drugs tailored specifically for children and the growing demand for them.

Speaking at the launch of the campaign in London last December, Dr Howard Zucker, WHO’s assistant director-general, said more than 50% of children in developed countries take off-label or unlicensed medicines.