FDA urges not to give cough, cold syrups to kids under 2

Drugs may cause "serious and potentially life-threatening side effects" in a small number of cases.

By JUDY SIEGEL-ITZKOVICH
The US Food and Drug Administration (FDA) declared Thursday that widely used non-prescription cough and cold medicines should not be given to babies and toddlers under the age of two, as they may cause "serious and potentially life-threatening side effects" in a small number of cases. The FDA will decide within the next few months whether over-the-counter (OTC) anti-histamines, decongestants and syrups that suppress coughs should be added to the list of drugs not recommended to children up to the age of six. After the FDA issued a "recommendation" last summer not to give anti-cough and -cold syrups to children under two, US pharmaceutical companies pulled off the shelves a variety of OTC products marketed specifically for babies and toddlers. It also said these syrups weren't effective in young children. But the FDA noted that since last August many "desperate" US parents continue to give their young children such syrups when they cough endlessly and are unable to fall sleep. That is why the new FDA message was made stronger. The pleasant-tasting syrups have dispatched nearly 2,000 young children to US emergency rooms over the past two years, according to the US Centers for Disease Control and Prevention in Georgia. Since the syrups are meant only to alleviate symptoms, but not to cure viral conditions, which eventually go away by themselves, the FDA believes there is no reason to take even a small risk. Instead, the FDA recommends drinking warm beverages, leaving humidifiers in the child's room and using salty-water nose drops. Pharmacist Rachel Gutman, who is in charge of pharmaceutical licensing at the Health Ministry's pharmaceutical division, said that in Israel, physicians may still suggest such syrups to young children or prescribe them. The ministry previously issued a statement that anti-cough and -cold syrups are not meant for babies and small toddlers. If a pharmacist is asked to sell such syrups, he or she should ask the customer the age of the patient, Gutman said. The ministry has not received any reports of serious side effects in children given the syrups and does not know how many packages are sold in Israel. If a syrup for coughs or colds is labelled that it is for children, the package exterior must say it is not recommended for those under the age of two, Gutman added. Parents are urged not to overdose children with syrups, and that if they administer them, this should be done with a special drug-measuring eyedropper or spoon and not an ordinary kitchen spoon, whose size varies.