FDA Restricts the Use of Codeine and Tramadol Medications in Children

The FDA has restricted the use of prescription codeine pain and cough medicines and tramadol pain medicines in children.  Side effects of these medicines in children under 12 include slowed or difficult breathing and death.  The FDA also warns against the use of codeine and tramadol medicines in breastfeeding mothers.

They are now requiring the following changes to all prescription labels containing these drugs:

  • Contraindication to codeine and tramadol labels warning that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years.
  • Contraindication to tramadol label warning against its use in children younger than 18 years after tonsil/adenoid surgery.
  • Warning label recommending against its use in children between 12 and 18 years with obstructive sleep apnea or severe lung disease.
  • Strengthened warning that breastfeeding is not recommending when taking codeine or tramadol.

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