Parent Alert: Drugmakers alter children’s cold medicine labels once again

Under pressure from pediatricians, concerned parents, and the FDA, makers of over-the-counter cold medicines have made another concession in the marketing and labeling of such medicines for young children. The debate over the safety and effectiveness of using kids’ cold and cough medicines is likely far from resolved, however.

The Consumer Healthcare Products Association (CHPA), which represents companies including Johnson & Johnson (Tylenol Plus and Pediacare), Novartis (Triaminic), and Wyeth (Robitussin and Dimetapp), announced a movement last week to re-label cold medicines by making the lowest age group in dosage instructions 4-year-olds instead of 2-year-olds. A quick check at my local grocery yesterday found that the changes are already showing up on the shelves.

Once again I imagine parents will be confused over the label changes, as this is not an outright product ban or recall. The debate has been raging for years, but came into the public eye last fall when the FDA stepped up its review and manufacturers voluntarily took cough and cold medicines aimed at infants off the shelves, leaving only products aimed at the two-and-up category.

The latest change simply alters the labels on those same products to target children aged four and above and was made in response to FDA findings that most adverse events (primarily misuse or unsupervised use leading to overdoses) occur in children below age 4. Manufacturers are also improving warnings, child-resistant packaging, and dosing implements to help prevent misuse and are conducting research and educational programs. These changes apply to multi-symptom and single-ingredient cold and cough treatments, not to single-ingredient fever reducers or allergy preventatives. Details for concerned parents can be found in this FDA statement and the CHPA information site, with a full product list here.

As for the product manufacturers, they don’t seem to be too concerned about major revenue losses resulting from the changes. Overall, sales of children’s cold medicines were reportedly around $300 million in 2007. The recent changes bring no actual reduction in the number of products on the shelves, and manufacturers maintain that the medicines are safe when used as directed. Some critics believe that the manufacturers are simply making concessions to delay the implementation of tighter restrictions by the FDA.

While I believe that this recent development will most likely prove to be a positive step towards preventing misuse, I also think that a final resolution needs to be made by the FDA before any additional voluntary measures are made by manufacturers that may only serve to further confuse consumers. Unfortunately the FDA is still reviewing data, including an expert panel’s recommendation from last year that cold medicines for children under 6 be taken off the shelves (some advocates for change believe that children under 12 receive no benefit and could experience harmful side effects from the medicines), and it could take years for the final rulemaking decisions to be made.