Show news: from last 30 days (default), 60 days, 90 days, last visit or all

FDA restricts codeine and tramadol in children and adolescents

26th April 2017

As part of an on-going safety review, the FDA have now further restricted the use of codeine and tramadol. The following restrictions apply:

  • codeine is contra-indicated for the treatment of pain or cough in children <12 years
  • tramadol is contra-indicated for the treatment of pain in children <12 years
  • codeine and tramadol are contra-indicated in children <18 years to treat pain after surgery to remove the tonsils and/or adenoids
  • it is recommended that codeine and tramadol are not used in adolescents 12−18 years who are obese, or have conditions such as obstructive sleep apnoea or severe lung disease, which may increase the risk of serious breathing problems
  • it is recommended that codeine and tramadol are not used by breastfeeding mothers.

Editor’s note: The restrictions for codeine reflect those issued in the UK by the MHRA in April 2015 (for cough) and July 2013 (for pain). The MHRA have not specifically highlighted any restrictions in the UK for tramadol, currently tramadol is unauthorized for use in children <12 years.

click here to view