The US Food and Drug Administration (FDA) has required safety label changes that will contraindicate the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years.
The announcement was made following an extensive review of available data and expert advice shared at meetings in regard to the use of opioid-containing cough and cold products in pediatric patients. Members of the expert roundtable who conducted this review concluded that the serious risks of these medicines outweigh their potential benefits in this patient population.
The new safety labeling changes expand the ones issued by the FDA in 2017, which restricted the use of codeine in children younger than 12 years due to a specific risk of ultra-rapid metabolism in certain patients.
The new labeling will also include updated safety information for adult use that are consistent with the labeling of other drug products that contain opioids, such as immediate-release opioid analgesics and extended-release and long-acting opioid analgesics.
FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use [press release]. US Food and Drug Administration. January 11, 2018. https://www.fda.gov/NewsEvents/Newsroom/Press Announcements/ucm592109.htm. Accessed on January 12, 2018.