FDA restricts use of codeine, tramadol in children

July 31, 2017

The Food and Drug Administration has been warning against the use of codeine and tramadol in children younger than 12 due to serious risks, including breathing issues and death.

The pain medicines also should be restricted in some older children as well, FDA notes. Single-ingredient codeine and products that contain tramadol are FDA-approved only for adult use. The agency also is recommending against the use of codeine and tramadol in breastfeeding mothers due to potential harm to their infants.

Healthcare professionals should consider recommending over-the-counter or other FDA-approved prescription medicines for pain management in children, particularly those with certain genetic factors, obesity or obstructive sleep apnea and other breathing issues, according to FDA.

FDA in 2013 included a Boxed Warning on the codeine drug label that warned against prescribing the drug to children to treat pain following surgery to remove tonsils or adenoids.

For more information, visit the FDA website: www.fda.gov/Drugs/DrugSafety/ucm549679.htm