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

Henrietta Strickland
January 13, 2018

The new warnings are consistent with the labels on other drug products with opioids, including painkillers.

The labels will also warn adult users about the risks of addiction, overdose and death.

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. 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.

The new warning follows an extensive FDA review of data and a meeting of the agency's Pediatric Advisory Committee in September.

The US Food and Drug Administration (FDA) on Thursday announced safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone as the risks of these medicines outweigh their benefits in children younger than 18.

Gottlieb added that the FDA is taking steps to assure parents that treating the common cold or cough is possible without prescription opioid medicine. 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. Common side effects of opioids include headache, dizziness and vomiting.

"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.

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

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

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

Other reports by Click Lancashire

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