This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Submit a response
Right arrow View responses
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow E-mail this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My File Cabinet
Right arrow Download to citation manager
Right arrowRequest Permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via CrossRef
Right arrow Citing Articles via Web of Science (4)
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Moore, T. J.
Right arrow Articles by Blaisdell, C. J.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Moore, T. J.
Right arrow Articles by Blaisdell, C. J.
Related Collections
Right arrow Therapeutics & Toxicology
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us   Add to Digg   Add to Facebook   Add to Reddit   Add to Technorati   Add to Twitter  
What's this?

PEDIATRICS Vol. 110 No. 5 November 2002, pp. e53

ELECTRONIC ARTICLE

Reported Adverse Drug Events in Infants and Children Under 2 Years of Age

Thomas J. Moore*, Sheila R. Weiss, PhD{ddagger},§, Sigal Kaplan, BPharm§ and Carol J. Blaisdell, MD||

* Center for Health Services Research and Policy, George Washington University School of Public Health and Health Services, Washington, DC
{ddagger} School of Medicine, University of Maryland, Baltimore, Maryland
§ School of Pharmacy, University of Maryland, Baltimore, Maryland
|| Division of Pediatric Pulmonology and Allergy, University of Maryland School of Medicine, Baltimore, Maryland

--> Objective. To characterize risks to infants and young children from drugs and biological products that were identified in spontaneous adverse event reports submitted to the US Food and Drug Administration.

Methods. Of >500 000 MedWatch adverse event reports received by the Food and Drug Administration from November 1997 through December 2000, we identified 7111 reports about infants and children younger than age 2. The reports were analyzed for health outcome (eg, death, hospitalization, congenital anomaly), principal suspect drug, and whether the route of drug exposure was direct administration or through the mother in the perinatal period.

Results. Drug therapy was associated with an average of 243 reported deaths annually over the 38-month study period, with 100 (41%) occurring during the first month of life and 204 (84%) during the first year. In 1432 (24%) reported adverse event cases of all levels of severity, exposure to the drug was from the mother during pregnancy, delivery, or lactation. Although 1902 different drugs, biological products, and other chemicals were identified in the reports, only 17 drugs or biological products were a suspect in 54% of all serious and fatal adverse events in drugs administered directly.

Conclusion. Adverse reactions to drug therapy are a significant cause of death and injury in infants and children under 2 years of age. Drugs administered to the mother in the perinatal period constituted a major route of exposure to adverse drug advents. These results underscore the need for additional drug testing in the youngest pediatric patients and for carefully weighing the risks versus benefits of medication.

Key Words: infant • child • adverse drug reaction reporting systems • drug therapy

Abbreviations: FDA, US Food and Drug Administration • AERS, Adverse Event Reporting System • HIV, human immunodeficiency virus

Received for publication Apr 10, 2002; Accepted Jul 16, 2002.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Facebook Facebook   Add to Reddit Reddit   Add to Technorati Technorati   Add to Twitter Twitter    What's this?


This article has been cited by other articles:


Home page
 Am J Health Syst PharmHome page
G. S. Takata, C. K. Taketomo, S. Waite, and for the California Pediatric Patient Safety Initia
Characteristics of medication errors and adverse drug events in hospitals participating in the California Pediatric Patient Safety Initiative
Am. J. Health Syst. Pharm., November 1, 2008; 65(21): 2036 - 2044.
[Abstract] [Full Text] [PDF]

Home page
 Arch. Dis. Child.Home page
K Cheng, S Masters, T Stephenson, R Cooke, R Ferner, M Ashworth, and A J Nunn
Identification of suspected fatal adverse drug reactions by paediatricians: a UK surveillance study
Arch. Dis. Child., July 1, 2008; 93(7): 609 - 611.
[Abstract] [Full Text] [PDF]

Home page
 Arch. Dis. Child.Home page
C. Stebbing, I. C K Wong, R. Kaushal, and A. Jaffe
The role of communication in paediatric drug safety
Arch. Dis. Child., May 1, 2007; 92(5): 440 - 445.
[Abstract] [Full Text] [PDF]

Home page
 cfpHome page
S. J. Genuis
An ounce of prevention: A pound of cure for an ailing health care system
Can Fam Physician, April 1, 2007; 53(4): 597 - 599.
[Full Text] [PDF]

Home page
 cfpHome page
S. J. Genuis
Une once de prevention: Prescription pour un systeme de sante en dif_culte
Can Fam Physician, April 1, 2007; 53(4): 605 - 607.
[Full Text] [PDF]

Home page
 JAMAHome page
H. G. C. Van Spall, A. Toren, A. Kiss, and R. A. Fowler
Eligibility Criteria of Randomized Controlled Trials Published in High-Impact General Medical Journals: A Systematic Sampling Review
JAMA, March 21, 2007; 297(11): 1233 - 1240.
[Abstract] [Full Text] [PDF]

eLetters:

Read all eLetters

Adverse Events and Attributing Causality
David M Reith
Pediatrics Online, 17 Nov 2002 [Full text]
Safety First
John Fryer
Pediatrics Online, 18 Nov 2002 [Full text]