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

FDA mandates "adult use only" labeling for prescription cough and cold meds containing codeine or hydrocodone

Officials with the FDA have announced labeling changes to prescription opioid cough and cold medications that contain codeine or hydrocodone. As the age range has been changed for prescription opioid cough/cold products with this action, the FDA is recommending that healthcare professionals provide alternative treatments for children (ie, dextromethorphan, prescription benzonatate) when treatment of cough is necessary.

"We know that any exposure to opioid drugs can lead to future addiction", Gottlieb said. 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 FDA says treating sick children with medicines that contain opioids poses "serious risks that don't justify their use".

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.

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Now, the FDA's latest action to revise safety labeling on some prescription cough and cold products expands the pediatric restrictions that were previously in place.

According to the agency, outside experts said that while some children's coughs require treatment, many get better on their own - including ones that are the result of respiratory infections. "Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits".

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

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

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

In 2015, the FDA also announced an investigation into the possible risks of using codeine-containing medicines to treat coughs and colds in children under 18.

There's more about this issue at the American Academy of Pediatrics.

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