Adverse drug reactions. A critical review

F. E. Karch and L. Lasagna

The data on adverse drug reactions (ADRs) are incomplete, unrepresentative, uncontrolled, and lacking in operational criteria for identifying ADRs. No quantitative conclusions can be drawn from the reported data in regard to morbidity, mortality, or the underlying causes of ADRs, and attempts to extrapolate the available data to the general population would be invalid and perhaps misleading. To evaluate the impact as well as the causes of ADRs, representative populations, including general hospital and ambulatory patients of all medical specialties, must be studied, and operationally defined criteria must be used to establish the presence of an ADR in a prospective study that incorporates appropriate control populations. Similar studies on the benefits of drug use are needed to provide perspective on the risk-benefit aspects of drug therapy. Until such studies are performed, estimates of the nature and scope of the ADR problem can be only guesses.

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Detection and prevention of medication misadventures in general practice
Tam et al.
Int J Qual Health Care 2008;20:192-199.
ABSTRACT | FULL TEXT  

MR Imaging of Metronidazole-Induced Encephalopathy: Lesion Distribution and Diffusion-Weighted Imaging Findings
Kim et al.
Am. J. Neuroradiol. 2007;28:1652-1658.
ABSTRACT | FULL TEXT  

Systematic Review of the Incidence and Characteristics of Preventable Adverse Drug Events in Ambulatory Care
Thomsen et al.
The Annals of Pharmacotherapy 2007;41:1411-1426.
ABSTRACT | FULL TEXT  

Effect of internal reporting criteria on suspected adverse drug reactions submitted to MedWatch
Smith et al.
Am J Health Syst Pharm 2006;63:949-952.
FULL TEXT  

Drug-Related Visits to the Emergency Department
Zed
Journal of Pharmacy Practice 2005;18:329-335.
ABSTRACT  

Computerized surveillance of adverse drug events in hospital patients
Classen et al.
Qual Saf Health Care 2005;14:221-226.
ABSTRACT | FULL TEXT  

Intratumoral Injection of Dendritic Cells Engineered to Secrete Interleukin-12 by Recombinant Adenovirus in Patients With Metastatic Gastrointestinal Carcinomas
Mazzolini et al.
JCO 2005;23:999-1010.
ABSTRACT | FULL TEXT  

Psychiatric side-effects of medications: recent developments
Turjanski and Lloyd
Adv. Psychiatr. Treat. 2005;11:58-70.
ABSTRACT | FULL TEXT  

Phase I Trial of Intratumoral Injection of an Adenovirus Encoding Interleukin-12 for Advanced Digestive Tumors
Sangro et al.
JCO 2004;22:1389-1397.
ABSTRACT | FULL TEXT  

Adverse Drug Events Associated with Hospital Admission
Peyriere et al.
The Annals of Pharmacotherapy 2003;37:5-11.
ABSTRACT | FULL TEXT  

Falling asleep at the wheel: Motor vehicle mishaps in people taking pramipexole and ropinirole
Olanow et al.
Neurology 2000;54:274-274.
FULL TEXT  

Patient Risk Factors for Adverse Drug Events in Hospitalized Patients
Bates et al.
Arch Intern Med 1999;159:2553-2560.
ABSTRACT | FULL TEXT  

Acute and reversible parkinsonism due to organophosphate pesticide intoxication: Five cases
Bhatt et al.
Neurology 1999;52:1467-1467.
ABSTRACT | FULL TEXT  

For COPD a Combination of Ipratropium Bromide and Albuterol Sulfate Is More Effective Than Albuterol Base
Campbell
Arch Intern Med 1999;159:156-160.
ABSTRACT | FULL TEXT  

Iatrogenic Diseases as a Reason for Admission to the Intensive Care Unit: Incidence, Causes, and Consequences
Darchy et al.
Arch Intern Med 1999;159:71-78.
ABSTRACT | FULL TEXT  

Identifying Adverse Drug Events: Development of a Computer-based Monitor and Comparison with Chart Review and Stimulated Voluntary Report
Jha et al.
J. Am. Med. Inform. Assoc. 1998;5:305-314.
ABSTRACT | FULL TEXT  

Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies
Lazarou et al.
JAMA 1998;279:1200-1205.
ABSTRACT | FULL TEXT  

Vaccine Safety Datalink Project: A New Tool for Improving Vaccine Safety Monitoring in the United States
Chen et al.
Pediatrics 1997;99:765-773.
ABSTRACT | FULL TEXT  

What constitutes good prescribing?
Barber
BMJ 1995;310:923-925.
FULL TEXT  

Is the Public being Protected? Prevention of Suboptimalmedical Practice Through Training Programs and Credentialing Examinations
Tamblyn
Eval Health Prof 1994;17:198-221.
ABSTRACT  

Opiate desensitization in a terminally ill cancer patient with pain: Physician assisted succor
Kaplan et al.
AM J HOSP PALLIAT CARE 1994;11:34-39.
 

Recognizing Hospital Adverse Drug Reactions
Savitsky
Journal of Pharmacy Practice 1989;2:203-208.
ABSTRACT  

Implementing a Hospital-Based Adverse Drug Reaction Reporting Program
Miwa
Journal of Pharmacy Practice 1989;2:214-220.
ABSTRACT