Children’s Cough Medicine Under Evaluation

Cough medicine

The FDA’s Pediatric Advisory Committee met this week to discuss the use of children’s medications containing opioids, specifically codeine and hydrocodone, to treat cough. The meetings follow a warning in April against the use of codeine and tramadol medications in children under 12, as well as updated labelling for opioid products.

The focus of the meeting was the use of prescription opioid products (specifically hydrocodone and codeine) for the treatment of pediatric cough, including current treatment practices and benefit-risk considerations. The Advisory Committee unanimously agreed that the risks of using children’s cough medicines containing certain opioids outweigh the benefits. The recommendation is part of ongoing efforts by the FDA to determine how and if opiates and opioids should be used in pediatric treatment.

With the current FDA priority of reducing opioid abuse, the meeting also aimed to consider the broader public health implications of opioid availability. While the committee focused on the two age groups of 6-12 and 12-18, some participants questioned the benefit of focusing on age limits at all. The concern is that adolescent opioid abuse results from diversion to non-patients, rather than misuse of medications by the patients they are prescribed for. The concern for pediatric patients is that there is little evidence of efficacy in treating a cough and significant evidence of adverse side effects from these medications. These effects occur when codeine is metabolised into morphine. This is problematic because this happens at an unpredictable rate, making it impossible to determine a safe dose.

As a result of the committee’s recommendations, the FDA may expand the warning issued in April to pediatric patients up to 18 years old. The committee also discussed codeine containing OTC medications would be dealt with in a similar way to prescription medications.

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