Today, a group of outside experts advised the FDA (Food and Drug Administration) to do what many pediatricians and family medicine doctors have been urging the FDA to do for some months now: study over-the-counter (OTC) cough, cold, and flu medicines more thoroughly before continuing to approve their use in kids. Right now, with little study but years of use, these medicines are permitted by the FDA for use in kids. However, when the expert advisors reviewed the sparse data for safety and effectiveness of the medicines in kids, they found no evidence that the medicines worked, and they also found evidence that the medicines caused side effects. Although most side effects are mild (irritability, drowsiness, upset stomach, etc.), overdoses of the medicines do occur and can be severe. The advisors to the FDA said that with no evidence for effectiveness, there is no reason to risk the side effects.
The advice of the outside experts was that the medicines not be used by kids younger than 6 years. Although some urged that even kids older than 6 not be given the mediciines, the experts could not agree on that recommendation.
The FDA does not have to take the advice of these experts – the votes were all “non-binding”. For the immediately forseeable future, the medicines will remain on the shelves – but there is no reason to use them for young kids. They don’t work.
For more on the pros (few) and cons (many) of OTC cough, cold, and flu medicines for kids, see Chapter 8 (Over-the-Counter or Over-the-Top) in Germ Proof Your Kids – The Complete Guide to Protecting (without Overprotecting) your Family from Infections.
Harley A. Rotbart, M.D.