Criteria for Outpatient Use Guidelines

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[Developed, October 2006; Revised, May 2010]

Information on indications for use or diagnosis is assumed to be unavailable. All criteria may be applied retrospectively; prospective application is indicated with [*].

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1.* Dosage

In 2004, promethazine received a “black box” warning with contraindications for use in children under two years of age and strengthened warnings for use in children two years of age and older. These revisions resulted from repeated reports to the Food and Drug Administration (FDA) of serious, life-threatening adverse events in children. Between 1969 and 2003, the FDA received 125 reports of adverse events in the pediatric population including respiratory depression, apnea, or cardiac arrest (n = 38); dystonic reactions (n = 29); unspecified central nervous system reactions (n = 24); seizures or seizure-like activity (n = 15); dermatologic reactions ((n = 12); and neuroleptic malignant syndrome (n = 5). All routes of administration were responsible for the outcomes observed with these events, which included hospitalization, life-threatening events, disability, and death.1-3

Due to the limitations placed on promethazine prescribing, all profiles for patients under two years of age containing prescriptions for promethazine will be reviewed.

References

1. Starke PR, Weaver J, Chowdhury BA.  Boxed warning added to promethazine labeling for pediatric use.  N Engl J Med. 2005;352:2653.
2. DRUGDEX® System (electronic version). Thomson Reuters (Healthcare) Inc., Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com.libproxy.uthscsa.edu.  Accessed May 7th, 2010.
3. Traynor K.  Promethazine contraindicated in young children, FDA warns.  Bethesda, MD:  American Society of Health-System Pharmacists.  April 26, 2006.  Available at:  http://www.ashp.org/news/ShowArticle.cfm?id=15056.  Accessed October 9th, 2006.
4. U.S. Department of Health and Human Services.  U.S. Food and Drug Administration.  Information for healthcare professionals - promethazine (marketed as Phenergan and generic products) (April 2006).  Available at:  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126465.htm.  Accessed May 7th, 2010.
5. Drug Facts and Comparisons.  Clin-eguide [database online].  St. Louis, MO:  Wolters Kluwer Health, Inc; 2010.  Available at:  http://clineguide.com.  Accessed May 7th, 2010.
6. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc; 2010. Available at: http://www.clinicalpharmacology.com. Accessed May 7th, 2010.

Prepared by: Drug Information Service, The University of Texas Health Science Center at San Antonio, and the College of Pharmacy, The University of Texas at Austin.