FDA issues warning about off‐label pediatric use of tramadol

Abstract

In a “Drug Safety Communication” posted September 21, the Food and Drug Administration warned that it is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. The FDA is evaluating all available information and will communicate final conclusions and recommendations to the public when the review is complete.