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FDA: Prescription Opioid Cough/Cold Meds No Longer Indicated for Children

12 January 2018

The Food and Drug Administration says kids and teens should never take prescription cough and cold medicines that contain opioids.

Additionally, labels will also include updated safety information for use in adults, including an expanded boxed warning notifying about the risks of misuse, abuse, addiction, overdose, death, and slow or hard breathing that can result from exposure.

The move is in response to the opioid addiction epidemic.

"We know that any exposure to opioid drugs can lead to future addiction", Gottlieb said.

The FDA says treating sick children with medicines that contain opioids poses "serious risks that don't justify their use".

Listed contraindications also warned mothers against breastfeeding when taking codeine or tramadol medicines, and recommended against use in adolescents between 12 and 18 years old who are obese and have conditions such as obstructive sleep apnea or severe lung disease.

Today's announcement follows an extensive review conducted by the FDA's Pediatric Advisory Committee on the benefits and risks associated with opioid antitussive use in pediatric patients. While today's action was meant to address prescription opioid cough/cold medications, the FDA is considering regulatory action for these OTC products as well. The upshot: "Although some pediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment".

The agency also noted that some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children, so it's important to check the labels.

FDA: Prescription Opioid Cough/Cold Meds No Longer Indicated for Children