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US Food and Drug Administration

FDA to examine opioid-containing cough medicine for children

The US drug safety watchdog is convening a panel of experts to consider the risks and benefits of opioid-containing prescription cough medicine for children.

The Pediatric Advisory Committee will specifically look at medicines containing hydrocodone or codeine and treatment practice to help the US Food and Drug Administration (FDA) reach a decision about the future use of these products for this patient group.

The FDA is inviting the public to register any comments about the issue ahead of the meeting on 11 and 12 September. 

Comments received by 28 August will be considered at the committee meeting. Comments received after that date and before the 13 September deadline will be considered by the FDA.

Announcing the meeting, the FDA’s commissioner Scott Gottlieb said in a statement that the issue was “complex” and was dependent on the length and severity of the cough symptoms, and on treating the underlying cause; not just trying to quieten the cough.

He said: “We look forward to a robust discussion at the meeting this fall and will continue to share updates with the public on the steps the agency is taking to address this important issue.”

The committee meeting follows the FDA’s decision in April to change the labelling of prescription opioid-containing cough products for children to increase patient safety and reduce potentially fatal risks. New labelling recommends that codeine-containing products should no longer be prescribed for children under the age of 12 — for any condition including coughs.

“It is vital we understand the potential complications that can occur when using opioid-containing medications in children, even according to labelled instructions. This is an area that the agency is continuing to evaluate,” said Gottlieb.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203442

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