Last week's voluntary withdrawal of several over-the-counter infant cold medicines, including widely marketed brands such as Tylenol, PediaCare and Triaminic, raises some troubling questions.
The recall was announced by the Consumer Healthcare Products Association, an industry trade group, which previously recommended that the Food and Drug Administration change dosing instructions for children younger than 2 on over-the-counter cough and cold medicine labels from "ask a doctor" to "do not use."
Drug makers are doing their best to spin the story. In announcing the news, they emphasized that the medicines were withdrawn because of potential misuse, not product safety, and said the change does not affect cold remedies for kids 2 and older.
What they didn't say, however, is that both of those claims are being debated.
In response to a petition filed by the Baltimore City Health Department commissioner and signed by 14 physicians, two FDA advisory committees were scheduled to discuss these issues Thursday and Friday. The petition argues that over-the-counter cough and cold medicines are neither safe nor effective for children younger than 6 and urges the FDA to educate the public and require manufacturers to include this disclaimer on product labels.
"Your child's safety is our number one priority," promises McNeil Consumer Healthcare, the Johnson & Johnson subsidiary that makes Tylenol and PediaCare, in large letters at the top of a statement about the recall on its website.
Yet, if that were really true, the labels on medicines marketed to young children would have left nothing open to interpretation. Instructing parents to "ask a doctor" before giving a cold remedy to a child younger than 2 creates the expectation that doctors have access to evidence-based dosing information and implies that the medicine can safely be given to such children under a doctor's supervision.