FDA: Risks of cold meds with opioids outweigh benefit for kids

The Food and Drug Administration on Thursday said children should no longer ingest cold-and-cough medicines that contain opioids.

Agency officials decided the risks tied to substances such as codeine and hydrocodone outweigh the benefits for cold sufferers under age 18.

As a result, labels will now say the products should only be used by adults.

The FDA also issued a “boxed” warning — its most prominent — to warn all ages that misuse of cough medicines containing opioids could result in overdoses and even death, or slowed or difficult breathing.

“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children,” said FDA Commissioner Scott Gottlieb. “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 agency said caregivers should read the labels of cough medicines carefully and explore alternatives.

“It’s critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone,” Dr. Gottlieb said. “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.”