Provider Alert! Codeine and Tramadol should NOT be prescribed for children

Provider Alert! Codeine and Tramadol should NOT be prescribed for children

On April 20, 2017 the US Food and Drug Administration (FDA) issued a statement that CODEINE is CONTRAINDICATED for treatment of pain or cough for children under 12 years. The also WARN against its use in adolescents 12-18 years old, especially those with obesity, obstructive sleep apnea, or severe lung disease.   The FDA considers TRAMADOL to be CONTRAINDICATED for children younger than 18 to treat pain from tonsillectomy or adenoidectomy.   Note that Tramadol is not FDA approved for use in children.

The FDA notes reports of serious breathing problems and deaths from use of codeine and/or tramadol in children. Some children metabolize codeine and tramadol much faster to their active form (called ultra-rapid metabolism) causing potentially dangerously high levels to accumulate in their bodies too quickly. Codeine is a prodrug that is metabolized to morphine.

This advice is consistent with the September 2016 Policy Statement from the American Academy of Pediatrics entitled, Codeine: Time To Say “No”.

In continued efforts to ensure the quality of care delivered to our members, Texas Children’s Health Plan will be monitoring prescriptions of Codeine and Tramadol to our pediatric members.

List of Prescription Codeine and Tramadol Pain and Cough Medicines

Medicines Containing Codeine Medicines Containing Tramadol
Codeine Sulfate Conzip
Butalbital, Acetaminopen, Caffeine, and Codeine phosphate Ultracet
Fiorinal with codeine Ultram
Soma Compound with codeine Ultram ER
Tylenol with codeine Generic products containing tramadol
Promethazine with codeine (cough)
Prometh VC with codeine (cough)
Triacin-C (cough)
Tuxarin ER (cough)
Tuzistra-XR (cough)
Generic products containing codeine
Medicines Containing Dihydrocodeine


FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. US Food and Drug Administration April 20, 2017.

Tobias JD, Green TP, Coté CJ, AAP Section on Anesthesiology and Pain Medicine, Aap Committee On Drugs. Codeine: Time To Say “No”. Pediatrics. 2016;138(4):e20162396.

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