Cough Syrup Containing Opioids Is Dangerous for Kids: FDA

Cough Syrup Containing Opioids Is Dangerous for Kids: FDA

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.

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.

Prescription opioid cough and cold medicines that contain codeine or hydrocodone are being stripped of their indications to treat cough in kids, FDA announced Thursday (Jan. 11). For those children in whom cough treatment is necessary, alternative medicines are available.

But health officials say that shouldn't be a problem as most coughs don't need any treatment. "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".


Common adverse effects of opioid therapies include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache, according to the FDA. The contraindication - FDA's strongest warning - alerted patients that codeine should not be used to treat pain or cough in children younger than 12 years old, due to ultra-rapid metabolism being reported in patients.

"The opioid epidemic has many origins, but can begin with exposure to [opioids] at young ages", he said.

So what's the advice for parents who may be using these medicines for their child already?

The F-D-A says it is revising warnings on such products, and will label them for use *only* in adults over age 18.

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