Document Detail

Reported adverse reactions to and consumption of nonsteroidal anti-inflammatory drugs in Denmark over a 17-year period.
MedLine Citation:
PMID:  2966038     Owner:  NLM     Status:  MEDLINE    
Over the 17-year period 1969-1985, 2,721 reports of 3,521 suspected adverse drug reactions (ADRs) associated with non-steroidal anti-inflammatory drugs (NSAIDs) were submitted to the Danish Committee on ADRs. The results are presented together with the consumption of each drug during the same period. The total sale of NSAIDs showed a four-fold increase during the 17 years, the average corresponding to a permanent intake by 2.2% of the population. The number of reported ADRs per defined daily dose (DDD) sold was markedly lower for "older" drugs like the butazones, indomethacin, ibuprofen, naproxen, ketoprofen, and fenoprofen than for the drugs marketed during the last decade. These differences could not be accounted for by the well-known biases attached to spontaneous ADR reporting. Of 67 fatal reactions, 25 were due to bleeding or perforation of a gastric ulcer, mostly during treatment with indomethacin and naproxen, and in elderly people, and 27 were caused by bone marrow depression or leukaemia, begun mostly during treatment with butazones, but some with indomethacin and naproxen as well. It is pointed out that all reports on fatal bone marrow depression associated with butazones were submitted before 1976 and that the fact that none have been received since that time could be a result of better understanding of the proper dosage of the drug.(ABSTRACT TRUNCATED AT 250 WORDS)
H Kromann-Andersen; A Pedersen
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Danish medical bulletin     Volume:  35     ISSN:  0907-8916     ISO Abbreviation:  Dan Med Bull     Publication Date:  1988 Apr 
Date Detail:
Created Date:  1988-06-03     Completed Date:  1988-06-03     Revised Date:  2009-11-19    
Medline Journal Info:
Nlm Unique ID:  0066040     Medline TA:  Dan Med Bull     Country:  DENMARK    
Other Details:
Languages:  eng     Pagination:  187-92     Citation Subset:  IM    
Commitee on Adverse Drug Reactions, National Board of Health, Denmark.
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MeSH Terms
Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
Drug Eruptions / etiology
Drug Utilization
Drug-Induced Liver Injury / etiology
Gastrointestinal Diseases / chemically induced
Hematologic Diseases / chemically induced
Kidney Failure, Acute / chemically induced
Metabolic Diseases / chemically induced
Substance-Related Disorders / etiology
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal

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