Boxed warning added to promethazine labeling for pediatric use [5]

New England Journal of Medicine

Volumn 352, Issue 25, 2005, Pages 2653-

  Starke, Peter R ^a   Weaver, Joyce ^a   Chowdhury, Badrul A ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PROMETHAZINE;

AGITATION; APNEA; CENTRAL NERVOUS SYSTEM DISEASE; DRUG FATALITY; DRUG LABELING; DYSTONIA; EXTRAPYRAMIDAL SYMPTOM; FOOD AND DRUG ADMINISTRATION; HALLUCINATION; HEART ARREST; HUMAN; LETTER; NEUROLEPTIC MALIGNANT SYNDROME; NEUROTOXICITY; PEDIATRICS; PRIORITY JOURNAL; RESPIRATION DEPRESSION; SEDATION; SEIZURE; SIDE EFFECT; SKIN TOXICITY; ADOLESCENT; CHEMICALLY INDUCED DISORDER; CHILD; DRUG CONTRAINDICATION; INFANT; MORTALITY; PRESCHOOL CHILD; RESPIRATORY FAILURE; UNITED STATES;

ADOLESCENT; CHILD; CHILD, PRESCHOOL; DRUG LABELING; DYSTONIA; HUMANS; INFANT; PROMETHAZINE; RESPIRATORY INSUFFICIENCY; SEIZURES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 23344444423     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJM200506233522522     Document Type: Letter

References (4)

1. Hickson GB, Altemeier WA, Clayton EW. Should promethazine in liquid form be available without prescription? Pediatrics 1990;86:221-5.
2. Cote CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: analysis of medications used for sedation. Pediatrics 2000;106:633-44.
3. American Academy of Pediatrics Committee on Drugs. Reappraisal of lytic cocktail/demerol, phenergan, and thorazine (DPT) for the sedation of children. Pediatrics 1995;95:598-602.
4. Specific requirements on content and format of labeling for human prescription drugs, 21 C.F.R. § 201.57 (2001).