No cold medicines for kids under 4, drug companies declare

Washington, October 8: Acting ‘out of an abundance of caution’, the makers of over-the-counter cough and cold medicines on Tuesday announced that such medicines should not be given to children younger than 4 years of age.

The voluntary announcement comes in the wake of intensifying criticism from consumer groups, lawmakers and pediatricians. The product labels of all over-the-counter pediatric cough and cold drugs will now carry the ‘do not use’ warnings, Consumer Healthcare Products Association (CHPA), a trade group for makers of over-the counter drugs proclaimed.

While the drug makers maintained that the pediatric cough and cold medicines are safe, the announcement comes “out of an abundance of caution and in an effort to promote the safe and appropriate use of these medications."

"Research shows that dosing errors and accidental ingestions, not the safety of the ingredients themselves when properly dosed, are the leading causes of rare adverse events in young children," Linda Suydam, president of the Consumer Healthcare Products Association averred.

The new guidelines, Suydam said, "reflect industry's overall commitment to the continued safe and appropriate use of children's oral over-the-counter cough and cold medicines."

Meanwhile, pediatricians welcomed the announcement made by over-the-counter drug manufacturers. "It's a huge step forward," said Dr. Joshua Sharfstein, Baltimore's health commissioner, "There is no evidence that these products work in kids, and there is definitely evidence of serious side effects."

Despite low evidence that such over-the-counter remedies are actually effective in curing cold symptoms in children, an estimated 10 percent of American kids are administered one or more cough and cold medications during a given week.

According to U.S. Centers for Disease Control and Prevention, an estimated 7,000 American children under the age of 11 require immediate medical intervention annually because of problems caused by cough and cold medications.

While the U.S. Food and Drug Administration has recommended against the use of over-the-counter cold medicines for children between 2 and 6 years old, the federal agency is yet to rule a final decision.

Worried that the immediate ban might cause parents to give adult medicines to their children, Dr. John Jenkins, head of the FDA's Office of New Drugs, said "We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation."

Pediatricians recommend:

• If your child has cold symptoms the best remedies include; plenty of rest, fluids, cool or warm mist and saline nose drops.
• Never give cold or cough medicine to a child younger than 2 as these drugs can have serious and even life-threatening side effects.
• If your child is feverish give him infant acetaminophen or ibuprofen.
• Always read out product labels carefully.
• Never administer adult medications to children.
• Use a special measuring device to get the correct dose.