FDA steps in to prohibit codeine cough syrups for children

pharmafile | January 12, 2018 | News story | Medical Communications FDA, biotech, drugs, pharma, pharmaceutical 

The FDA has announced that it will require all labels to state that cough syrups containing codeine or hydrocodone are not suitable for those under the age of 18.

On top of this, additional warning and safety information will be provided for adult use, including the most pronounced warning that can be included, a Boxed Warning.

FDA Commissioner, Scott Gottlieb, explained how the move would positively contribute to the effort against the crisis: “Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. 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.”

The warnings that have been introduced will bring cough syrup in line with other with other opioid-containing painkillers.

The action follows on from previous advice by the FDA, released in April, that warned against the use of codeine-containing cough syrup to those under 12.

At the time, this advice was supplied due to the safety risks of the products in children; with the agency noting that such products can cause serious breathing problems and even death.

The tack was slightly different in the latest release, with more of a focus on opioid-abuse prevention.

The press release concluded, on the issue of treatments for coughs and cold, that: “Experts indicated that although some paediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment. Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits.”

The move comes as part of the wider strategy against the growing opioid crisis that is engulfing North America. Only yesterday, the state of Pennsylvania became the latest to declare a state of emergency over opioid abuse problems. Pennsylvania has the fourth-highest overdose death rate in the US.

Ben Hargreaves

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