Over-the-Counter Cough and Cold Medicine for Children

When drugmakers announced that they no longer recommend over-the-counter cough and cold medicines for children under 4, they forgot to mention that it was the government’s idea. Although pediatricians and a group of independent advisors have asked the FDA to ban cold products for children under 6, the agency decided to go against such recommendation by setting the cutoff at age 4. The FDA’s maneuvering on this issue is an example of how government officials and drugmakers accommodate each other’s "needs" after rounds of private discussions. According to Baltimore’s health commissioner, Dr. Joshua Sharfstein, there is a delicate dance between how much legal authority the FDA has and their use of the bully pulpit for getting some sort of compromise.

The problem here is that there is little evidence that the widely used over-the-counter medicines really work in children. These cold and cough remedies, with fruity flavors specifically marketed for kids, have been known to cause serious and potentially life-threatening side effects. These warnings come because of several concerns: parents can very easily give the wrong dosage; parents are given these medicines to children without consulting their pediatrician; these medicines do not appear to be effective on infants and toddlers; and there have been rare, but serious side effects from convulsions, rapid heart rates, and reduced levels of consciousness. The fact of the matter is that 7,000 kids go to the emergency room each year for taking over-the-counter cough and cold medicines.

Although studies have shown that cough and cold products are ineffective in treating symptoms of children under 6 years old and may pose serious risks, FDA officials maintain that it settled on age 4 after a careful review of hospital data. Unfortunately, we’ll never know the significance of these data, because the agency has refused to release them to the public.