Drug Safety Warnings and Updates: July-September 2017

Teresa Rubio, PharmD

Disclosures

January 03, 2018

Editorial Collaboration

Medscape &

In This Article

Some Codeine-containing Cough Preparations

For more on this Drug Safety Labeling Change, click here and here.

Updated Boxed Warning

WARNING: ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children

Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. Promethazine HCl and codeine phosphate oral solution is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see CONTRAINDICATIONS). Avoid the use of promethazine HCl and codeine phosphate oral solution in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine. (See WARNINGS—Ultra-Rapid Metabolism of Codeine and Respiratory Depression.)

Promethazine and Respiratory Depression in Children

Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients. Children may be particularly sensitive to the additive respiratory depressant effects when promethazine is combined with other respiratory depressants, including codeine. (See WARNINGS—Promethazine and Respiratory Depression in Children.)

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