FDA Is Trying To Keep Cough Medicines Containing Opioids From Kids

Henrietta Strickland
January 13, 2018

Officials with the FDA have announced labeling changes to prescription opioid cough and cold medications that contain codeine or hydrocodone.

The newly updated Boxed Warning on these medicines will also warn adult users "about the risks of misuse, abuse, addiction, overdose and death, and slowed or hard breathing that can result from exposure to codeine or hydrocodone", the agency added.

FDA Commissioner Scott Gottlieb, MD, expressed concern for young children's unnecessary exposure to opioids in a statement.

In addition to limiting use in children following a comprehensive assessment of the risks and benefits of these products, labeling for adult-only use of prescription opioid cough and cold medicines that contain codeine or hydrocodone will also now include updated safety information.

Medicines containing codeine or hydrocodone are now required to have a label indicating they're for people age 18 and over.

Thursday's action expands a previous warning, issued by the agency last April, against the use of prescription medications containing codeine and tramadol for children younger than 12.

The move comes after a 2017 decision by the FDA to add its strongest warning - a "contraindication" - to labeling for prescription products containing codeine.

In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said. Common side effects of opioids include headache, dizziness and vomiting.

"Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated".

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. 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.

Other reports by Click Lancashire

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