The US Food and Drug Administration has announced measures to limit the use of opioid-containing cough and cold preparations by children
The FDA says the safety labelling changes will affect prescription opioid cough and cold medicines containing codeine or hydrocodone.
The move follows efforts last year to restrict the use of codeine- or tramadol-containing OTC medicines in children and breastfeeding mothers.
After the new safety labelling changes are made, codeine and hydrocodone-containing prescription products will no longer be indicated to treat cough in any paediatric population and will be labelled for use only in adults, aged 18 years and over.
Labelling is also being updated with additional safety information for adult use, including an expanded Boxed Warning – the FDA’s most prominent warning – notifying patients about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing which may result from taking codeine or hydrocodone.
The changes take place against a backdrop of the prescription opioid addiction crisis in the US, and the FDA says they are one example of its work to protect patients for whom the risks of opioid products outweigh the benefits.
“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children,” says FDA Commissioner Scott Gottlieb.
“We know that any exposure to opioid drugs can lead to future addiction. It’s become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population.
“It’s critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone,” he says.
“At the same time we’re taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products.”
Australia’s upschedule of all OTC codeine-containing cough-and-cold and analgesic products is now only two weeks away.