FDA Changes Safety Label for Pediatric Prescription Opioid Medication


Those medications include Codeine and Oxycodone.

Prescription opioid cough and cold medicines that contain codeine or hydrocodone are being stripped of their indications to treat cough in kids, FDA announced Thursday (Jan. 11). The new label's safety warnings will be consistent with the labeling of other opioid-containing drug products, such as immediate-release opioid analgesics and extended-release and long-acting opioid analgesics. These changes include limiting the use of these agents to adults ≥18 years old, as well as the addition of new safety information regarding the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death to the Boxed Warning.

"We know that any exposure to opioid drugs can lead to future addiction", Gottlieb said.

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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.

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

The FDA also recommended against the use of these medications by women who are breastfeeding. "Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits", the FDA said in announcing the new labeling. The administration advises parents children prescribed codeine or hydrocodone to talk their health care professional about alternate treatment options.