FDA investigating off-label use of tramadol in children

The US Food and Drug Administration 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 says it is evaluating all available information and will communicate its final conclusions and recommendations to the public when the review is complete.

Health care professionals should consider prescribing FDA-approved pain medicines