New Warnings about Side Effects of Children’s Cough and Cold Medicines

Makers of over-the-counter (OTC) children’s cough and cold drugs indicated yesterday that they will add new product warnings that the drugs should not be used in children under 4 years old. However, consumer advocacy groups and experts have argued that there should be an outright ban on use of these drugs by children up to 6 years old.

The new warnings for children’s cough and cold drugs were announced by the Consumer Healthcare Products Association, an industry trade group representing the pharmaceutical industry.

Several children’s versions of popular over-the-counter drugs will be impacted, such as Novartis’ Triaminic, Johnson & Johnson’s Tylenol and PediaCare, Procter & Gamble’s NyQuil and Vicks, Wyeth’s Dimetapp and Prestige Brands’ Little Noses.

Side effects of children’s cough and cold drugs have been associated with reports of hallucinations, seizures and strokes. In addition, pediatricians and consumer groups have argued that there is no evidence to establish that the drugs are effective for young children.

Government estimates indicate that over 7,000 children are admitted to emergency rooms every year for treatment of side effects resulting from children’s cough and cold drugs, and the FDA has received reports of 123 children’s deaths linked to the use of over-the-counter and prescription antihistamines and decongestants between 1969 and 2006.

In response to the announcement by the drug industry, the prominent consumer group Public Citizen issued a statement indicating that the proposal is not enough. They have advocated for a restriction on use by children under 6, and indicate that the limit of 4 years old only represents a political compromise that was not based on scientific evidence.

“[The new warnings] will do little to protect all children from these ineffective and, therefore, needlessly dangerous products,” said Peter Lurie, M.D., Deputy Director of the Health Research Group at Public Citizen. “By announcing a 4 year-old-age restriction – halfway between the current voluntary limit of 2 years of age and the age limit of 6 requested in a petition submitted last year – the manufacturers are once again attempting to delay more definitive action by the Food and Drug Administration (FDA).”

Drug makers have maintained that their children’s products are safe when used as directed, and suggest that many of the adverse events tied to the drugs have been caused by unsupervised use. They believe that limiting the warning to children under four is appropriate because most of the overdose problems occur among children who are 2 year olds or 3 year olds.

The market for over-the-counter cough and cold drugs is a big industry in the United States, with over 800 products marketed to treat coughs, sore throats, runny noses and fevers. Approximately 95 million packages of oral children’s cough and cold drugs are sold every year, with annual sales of over $311 million.