FDA Changes Safety Label for Pediatric Prescription Opioid Medication

The US Food and Drug Administration (FDA) on Thursday announced safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone as the risks of these medicines outweigh their benefits in children younger than 18.

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 FDA said it conducted extensive reviews of available data and sought expert advice on opioid use in the treatment of childhood pain and cough.

The FDA pointed to known side effects of opioid medications, including "drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache".

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"It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone", he added.

The new warnings are consistent with the labels on other drug products with opioids, including painkillers. 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 FDA will remind parents that most coughs and colds don't need any treatment at all.

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

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One physician who's dealt with the aftermath of opioid overuse applauded the move.

It's always important to read medicine labeling, too - even if it's not obtained by prescription.

The agency said it is requiring manufacturers to change the wording on their labels to make clear that such products should not be used for anyone younger than 18.

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