Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2000-6-15
pubmed:abstractText
This article reports on a retrospective study in two major Norwegian hospitals of spontaneous reporting to the Adverse Drug Reaction Committee of the Norwegian Medicines Control Agency of adverse reactions from the use of oral contraceptives (OCs) among patients with a diagnosis of venous thromboembolism. In these two hospitals, 168 women between 15 and 44 were diagnosed with a first event of venous thromboembolism during the ten-year period up to the end og 1997; 69 of them were OC users at the time of diagnosis. Three medical records (4%) kept at the hospital contained information on a report of adverse drug reaction to the Norwegian Medicines Control Agency. The Agency's database of all spontaneous reports on adverse drug reactions contains 112 reports of venous thromboembolism in the context of OC use. These reports came from all over Norway during the ten-year period of our study; four of the reports came from the study hospitals. We conclude that venous thromboembolism during the use of OCs was underreported by more than 90%. This corresponds to estimates of underreporting of other adverse drug reactions from the use of various compounds, in Norway as well as in other countries.
pubmed:language
nor
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jan
pubmed:issn
0029-2001
pubmed:author
pubmed:issnType
Print
pubmed:day
30
pubmed:volume
120
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
336-8
pubmed:dateRevised
2008-7-16
pubmed:meshHeading
pubmed:year
2000
pubmed:articleTitle
[Reporting of adverse drug reactions to the Norwegian Drug Control Agency].
pubmed:affiliation
Seksjon for epidemiologisk forsking, Sintef Unimed, Trondheim.
pubmed:publicationType
Journal Article, English Abstract