liu.seSearch for publications in DiVA
Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • harvard1
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • oxford
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Spontaneously reported fatal suspected adverse drug reactions: A 10-year survey from Sweden
Linköping University, Department of Medicine and Care, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
Linköping University, Department of Medicine and Care, Clinical Pharmacology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre for Laboratory Medicine, Department of Clinical Pharmacology.
St. Olav University Hospital, Trondheim, Norway.
Linköping University, Department of Medicine and Care, Clinical Pharmacology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre for Laboratory Medicine, Department of Clinical Pharmacology.
2007 (English)In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 16, no 2, 173-180 p.Article in journal (Refereed) Published
Abstract [en]

Purpose: One of the main methods for monitoring the safety of marketed drugs is spontaneously reporting of suspected adverse drug reactions (ADRs). The objective of this study was to describe the pattern of spontaneously reported fatal adverse drug reactions (FADRs) by analysing data from the national spontaneous reporting system in Sweden. Methods: In Sweden it is compulsory to report all new or serious suspected ADRs to the Medical Products Agency. The information in these reports is stored in the national database SWEDIS (Swedish Drug Information System). All suspected FADRs reported to SWEDIS between 1 January 1995 and 31 December 2004 were reviewed and analysed. Results: During the study period 990 reports of FADRs were found. The main distribution of suspected FADRs was: haemorrhages (n = 603, 60.9%), blood and bone marrow dysfunction (n = 71, 7.2%), sudden death (n = 38, 3.8%) and pulmonary embolism (n = 30, 3.0%). Antithrombotic agents were the drugs most frequently implicated in the FADRS (n = 605, 61.1%). Vitamin K antagonists were reported in 453 cases (45.8%) and acetylsalicylic acid in 82 cases (8.3%). Among the fatalities with blood and bone marrow dysfunction methotrexate was the most frequently reported drug. For sudden death and pulmonary embolism, antipsychotics and oestrogen containing drugs, respectively, were most commonly reported. Conclusions: Bleeding complications amounted more than half of all reports of FADRS and vitamin K antagonists were implicated in most of these reports. However, as spontaneous reporting systems are primarily set up for signalling purposes, the data must be interpreted with utmost care. Copyright © 2006 John Wiley & Sons, Ltd.

Place, publisher, year, edition, pages
2007. Vol. 16, no 2, 173-180 p.
Keyword [en]
Adverse drug reaction; mortality; spontaneous reporting system; pharmacovigilance
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:liu:diva-42772DOI: 10.1002/pds.1263Local ID: 68688OAI: oai:DiVA.org:liu-42772DiVA: diva2:263629
Available from: 2009-10-10 Created: 2009-10-10 Last updated: 2017-12-13

Open Access in DiVA

No full text

Other links

Publisher's full text

Authority records BETA

Wester, KarinJönsson, AnnaHägg, Staffan

Search in DiVA

By author/editor
Wester, KarinJönsson, AnnaHägg, Staffan
By organisation
Clinical PharmacologyFaculty of Health SciencesDepartment of Clinical Pharmacology
In the same journal
Pharmacoepidemiology and Drug Safety
Medical and Health Sciences

Search outside of DiVA

GoogleGoogle Scholar

doi
urn-nbn

Altmetric score

doi
urn-nbn
Total: 73 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • harvard1
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • oxford
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf