FDA Pulls Pediatric Indications For Opioid Cough And Cold Medicines

Bottles of NyQuil left Tylenol center front and Theraflu right all containing acetaminophen appear together in Walpole Mass. Tuesday

The Food and Drug Administration says kids and teens should never take prescription cough and cold medicines that contain opioids. The makers of these medicines also will need to update their labeling to provide safety warnings consistent with the labeling of other opioid-containing drugs, and will feature an expanded Boxed Warning for adult use.

FDA Commissioner Scott Gottlieb, MD, expressed concern for young children's unnecessary exposure to opioids in a statement. Notably, the FDA advisory committees that have been responsible for assessing the suitability of utilizing opioids as treatment options for coughs and colds in pediatric populations have focused on two age groups: those 6 to 12, and those 12 to 18. That labeling restricted use to children aged 12 and over "due to a specific risk of ultra-rapid metabolism in certain patients", the FDA explained.

"We are taking this action after conducting an extensive review and convening a panel of outside experts".

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

In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said. "If the medicine prescribed for your child contains an opioid, talk to your child's health care professional about a different, non-opioid medicine", it said.

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Common adverse effects of opioid therapies include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache, according to the FDA.

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

"The opioid epidemic has many origins, but can begin with exposure to [opioids] at young ages", he said. Experts say parents should always read labels before giving their children any medicine, even if it's purchased over the counter.

In a few states, codeine cough medicine is still available for over-the-counter (OTC) dispensing.

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