Advertisement

FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products

Share This Page
FDA announced Thursday safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than age 18 years, saying the risks of the medicines outweigh their potential benefits in this population.

FDA announced Thursday safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than age 18 years, saying the risks of the medicines outweigh their potential benefits in this population. According to FDA, "After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older." Labeling for the drugs is also being updated with additional safety information for adult use, including an expanded boxed warning, warning of the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone. FDA Commissioner Scott Gottlieb, MD, said: "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 mandatory safety labeling changes follow an extensive review of available data and expert advice shared at meetings to explore the pediatric use of opioid-containing cough and cold products. An FDA drug safety communication noted, "Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated. For those children in whom cough treatment is necessary, alternative medicines are available," including OTC products such as dextromethorphan as well as prescription benzonatate products.

Ad Position: 
Bottom Center Aligned
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592109.htm

Advertisement

Related Content

block-views-related-content-block