FDA bans opioid cough medicines for kids under 18

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  • Due to risks of addiction, difficulty breathing, overdose, and more, the FDA will revise labels of opioid cough and cold medicines containing codeine or hydrocodone, banning their use in patients aged <18 years.

Why this matters

  • This decision comes at a critical time both during cold and flu season and amidst an opioid epidemic in the United States.
  • Opioid exposure is known to increase the risk for future addiction.

Key points

  • Prescription cough and cold medicines containing opioids codeine or hydrocodone will no longer be indicated for use in patients <18 years.
  • New labels will include updated safety information for use in adults ≥18 years consistent with safety labeling on immediate-release opioids and extended-release and long-acting opioids .
  • An accompanying Drug Safety Communication suggests healthcare providers tell parents that most coughs and colds do not require intervention and will resolve on their own, and to recommend over-the-counter medications for coughs that require intervention.
  • This decision was made after a meeting of outside experts determined the “risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.”