Johnson & Johnson, Wyeth and Novartis Consumer Health are among a number of companies that have decided to withdraw over-the-counter cough and cold medicines, all indicated for infants, from the US market because of a risk of overdose.

The move has been prompted by a US Food and Drug Administration (FDA) warning a couple of weeks back that it was considering adding a warning to the labeling to these products that they should not be used in children under two. The issue stems from potential product misuse, rather than any intrinsic safety issues.

An FDA advisory committee is meeting to discuss the labeling next week, prompted by a Citizen’s Petition filed earlier this year by a group of eminent physicians and state health officials that raised concerns about the safety and efficacy of cough and cold products in infants as well as children under six years of age.

The petition is trying to make it illegal for companies to promote these products for children aged under six, use images of small children, and include the terms ‘baby’ or ‘infant’ on the label.

News of the pulled products came from the Consumer Healthcare Products Association, a US trade organization representing the OTC medicines and dietary supplements industry, which emphasised that none of the withdrawals affect products sold for use in children aged over two.

Strengthening warnings

The CHPA and its member companies have asked the FDA to limit itself to strengthening the labels on all oral OTC children’s cough and cold medicines from "ask a doctor" before using to "do not use" in children under two years, but maintains that products for older children should still be available.

"These medicines are - and always have been - safe at recommended doses," commented Linda Suydam, president of the CHPA. On the topic of the citizen’s petition, she said: "The FDA has not called for a ban on medicines for children under six. Rather, the agency has presented a variety of internal and external recommendations for discussion at the upcoming advisory committee meeting.”

Some of the products that have been withdrawn contain pseudoephedrine – an ingredient that will be subject to severe restrictions later this year when new regulations come into force. The companies may well have decided that the cost of reformulating these products with alternative ingredients such as phenylephrine is prohibitive in light of the potential FDA-mandated clampdown.