Codeine – Not for Kids, Says FDA

When it comes to testing the effectiveness or safety of medications, kids are essentially left out in the cold. After all, how many parents want their child to be the test subject? The unfortunate result: We tend to find out whether children’s medications work or are safe with real-world experience and by applying adult experiences to child guidelines for use.

With the spotlight on pain medications, particularly the opioid class, the Food and Drug Administration recently strengthened its warning against children using prescription medications that contain codeine or tramadol – two opioid pain relievers. According to the FDA warning, which will be added to all relevant medication labels, children younger than age 12 should never be given any prescription med containing codeine for pain or cough, or tramadol for pain, and recommends against their use in children ages 12-18.

The FDA release announcing the label changes made the health risk clear: “These medications carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children.”

Note that while codeine is also an ingredient in some over-the-counter cold / flu medications, the FDA did not restrict their use in children, but did recommend parents talk to a doctor before administering them to their children.