FDA Revises Labeling to Limit Pediatric Opioid Use

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The agency is requiring safety label changes to limit the use of prescription opioid cough and cold medicines in children younger than 18 years old.

On Jan. 11, 2018, FDA announced safety labeling changes to prescription opioid cough and cold medicines containing codeine or hydrocodone to limit the use of products in children younger than 18 years old. According to the agency, these changes are being made in response to the risks associated with opioid-containing drugs.

Following the new safety labeling changes, these products will no longer be indicated for pediatric use to treat cough and will be labeled for use only in adults aged 18 years and older. The required safety labeling changes are based on an agency review of available data and expert advice to investigate the pediatric use of opioid-containing cough and cold products. The new labeling also expands pediatric restrictions put in place in 2017 when the agency required the addition of its strongest warning to the labeling of prescription codeine products, alerting that codeine should not be used to treat pain or cough in children younger than 12 years because of the risk of ultra-rapid metabolism in certain patients.

Additionally, labeling for these treatments will be updated with additional safety information for adult use, including an expanded boxed warning, the FDA’s most prominent warning, notifying about the risks of misuse, abuse, addiction, overdose, and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone. The new labeling will provide safety warnings on these products that are consistent with the labeling of other opioid-containing drug products, including immediate-release opioid analgesics and extended-release and long-acting opioid analgesics.


“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,” said FDA Commissioner Scott Gottlieb, MD, in an agency press release. “It’s critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone. 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.”

Source: FDA