FDA Updates Labeling for Opioid-Containing Medications to Limit Use in Children


The new warnings are consistent with the labels on other drug products with opioids, including painkillers. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Listed contraindications also warned mothers against breastfeeding when taking codeine or tramadol medicines, and recommended against use in adolescents between 12 and 18 years old who are obese and have conditions such as obstructive sleep apnea or severe lung disease.

Parents whose children are now prescribed a cough and cold medicine containing codeine or hydrocodone are encouraged to talk to their child's health care professional about other treatment options, the FDA advised.

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The FDA announced Thursday that it's requiring revisions to the safety labeling on such prescription opioid cough and cold medicines to indicate that the products no longer can be used to treat children - because their risks outweigh their potential benefits - and should be used only for adults 18 and older.

FDA Commissioner Scott Gottlieb, MD, expressed concern for young children's unnecessary exposure to opioids in a statement. We know that any exposure to opioid drugs can lead to future addiction.

The FDA says treating sick children with medicines that contain opioids poses "serious risks that don't justify their use". 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. For those children in whom cough treatment is necessary, alternative medicines are available.

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"It's commendable that the FDA is acting to expand safety use labeling not only for children and teens, but adults as well", said Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City.

The agency urged parents to read the labels on prescription bottles.

Some codeine cough medicines are available over the counter in a few states, FDA noted, saying it is also considering regulatory action for these products.

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