The FDA on Thursday said it will require a safety label change for cough and cold treatments containing codeine or hydrocodone to indicate these medications are no longer safe for use in children.
In its announcement, the FDA argued the risks associated with these medicines outweigh potential benefits, citing the fact that upper respiratory infections typically don't require treatment.
"Given the epidemic of opioid addiction, we're concerned about unnecessary exposure to opioids, especially in young children," said Scott Gottlieb, MD, FDA commissioner. "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."
The FDA will also update labeling on the medications to include additional information for adult use, highlighting the risk of misuse, abuse, addiction, overdose and death associated with opioids.
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