Parents across the country are being warned not to give cough and cold medicines to children under six because of “limited evidence” they work and rare but real risks of potentially serious reactions.
Health Canada is ordering manufacturers to relabel overthe-counter cough and cold medicines to state “do not use in children under six,” a move that will affect 722 products now authorized for sale in Canada.
The decision follows a Health Canada review of the medicines and consultation with a panel of outside experts. The agency says reports of misuse, overdose and rare side effects “have raised concerns about the use of these medicines in children under six.”
Between January 1995 and May 2008, Health Canada received 164 reports of adverse reactions in children under 12 related to cough and cold products; 105 were considered serious, including five deaths in children under the age of two. The youngest was four weeks old; the oldest, 20 months.
The reports are based on suspicion only and most of the children who died had serious underlying medical illnesses. But it’s believed only about one per cent of adverse drug reactions are ever reported under Canada’s voluntary reporting system. Reported side effects in children using over-thecounter cough and cold products include convulsions, increased heart rate, decreased consciousness, abnormal heart rhythms and hallucinations.
The active ingredients affected by the decision include antihistamines in cough and cold medicines, dextromethorphan and other “antitussives” used to treat coughs, expectorants used to loosen mucus, and decongestants.
Drug makers last year pulled over-the-counter children’s cough and cold products off Canadian store shelves amid fears the medicines could lead to an overdose and other potentially fatal reactions. At that time, Health Canada issued a warning to parents not to give cough and cold medicines to children under two, unless otherwise instructed to do so by a doctor.
According to Health Canada, the decision to expand that to kids under six is based on several factors, including the fact that there is no evidence they benefit children. The new decision does not apply to singleingredient children’s pain relievers and fever reducers.
“Cough and cold medicines have a long history of use in children, and reports of health problems related to the use of these products are very rare compared to their overall use,” Health Canada spokesman Dr. Marc Berthiaume, director of the marketed pharmaceuticals and medical devices bureau, told reporters during a conference call yesterday. “Parents can be reassured that there is no evidence that children who have used these medicines in the past are at risk of adverse events.”
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