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  • 1.
    Wester, Karin
    et al.
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Jönsson, Anna
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Diagnostics, Department of Clinical Pharmacology.
    Hägg, Staffan
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Diagnostics, Department of Clinical Pharmacology.
    Incidence of Suspected Drug-Related Deaths in a Swedish Population2007In: Pharmacoepidemiology and drug safety, Wiley , 2007, p. 196-Conference paper (Refereed)
  • 2.
    Wester, Karin
    et al.
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Jönsson, Anna K.
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Spigset, Olav
    Department of Laboratory Medicine, Children's and Women's Health, Norwegian University of Science and Technology, Trondheim, Norway.
    Druid, Henrik
    Department of Forensic Medicine, Karolinska Institute, Stockholm, Sweden.
    Hägg, Staffan
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Incidence of fatal adverse drug reactions: A population based study2008In: British Journal of Clinical Pharmacology, ISSN 0306-5251, E-ISSN 1365-2125, Vol. 65, no 4, p. 573-579Article in journal (Refereed)
    Abstract [en]

    What is already known about this subject

    • Although drugs generally are safe and effective therapies for numerous diseases, adverse drug reactions do occur and may even be fatal.

    • The incidence of fatal adverse drug reactions in hospitalized patients has been estimated to be approximately 5%.

    • In previous studies the incidence of fatal adverse drug reactions in hospitalized patients has been reported, but the incidence of fatal adverse drug reactions in the general population is largely unknown.

    What this study adds

    • Fatal adverse drug reactions account for approximately 3% of all deaths in the general population.

    • Haemorrhages amount to almost two-thirds of the fatal adverse drug reactions and antithrombotic agents are implicated in more than half of the suspected fatal adverse drug reactions.

    • Fatal adverse drug reactions are estimated to be the seventh most common cause of death in Sweden.

     

    Aims: To determine the incidence of fatal adverse drug reactions (FADRs) in a Swedish population.

     

    Methods: Every seventh randomly selected deceased in three counties in South-east Sweden during 1 January 2001–31 December 2001 was identified in the Cause of Death Register. Relevant case records (hospitals and/or primary care centres and medicolegal files) were reviewed to identify suspected drug-related fatalities.

     

    Results: Of 1574 deceased study subjects, 49 (3.1%; 95% CI 2.2%, 4.0%) were suspected to have died from FADRs. The most common suspected FADRs were gastrointestinal haemorrhages (n = 18; 37%), central nervous system haemorrhages (n = 14; 29%), cardiovascular disorders (n = 5; 10%), other haemorrhages (n = 4; 8%) and renal dysfunction (n = 3; 6%). The drugs most commonly implicated in FADRs were antithrombotic drugs (n = 31; 63%), followed by nonsteroidal anti-inflammatory drugs (NSAIDs) (n = 9; 18%), antidepressants (n = 7; 14%) and cardiovascular drugs (n = 4; 8%). Of all the 639 fatalities in hospital 41 (6.4%; 95% CI 4.5%, 8.3%) were suspected to be due to FADRs.

     

    Conclusions: The medical burden of FADRs is significant. Haemorrhages were seen in a majority of the FADRs; antithrombotic agents or NSAIDs were implicated in most of these events. These results suggest that preventive measures should be taken to reduce the number of deaths caused by drugs.

  • 3.
    Wester, Karin
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Health Sciences.
    Jönsson, Anna
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Health Sciences. Östergötlands Läns Landsting, Centre for Laboratory Medicine, Department of Clinical Pharmacology.
    Spigset, Olav
    Olso, Norge.
    Druid, Henrik
    Stockholm.
    Hägg, Staffan
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Clinical Pharmacology. Östergötlands Läns Landsting, Centre for Laboratory Medicine, Department of Clinical Pharmacology.
    Incidens av läkemedelsrelaterad dödslighet i Sverige2007In: Läkarsällskapets Riksstämma,2007, 2007Conference paper (Other academic)
  • 4.
    Wester, Karin
    et al.
    Linköping University, Department of Medicine and Care.
    Jönsson, Anna
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Clinical Pharmacology. Östergötlands Läns Landsting, Centre for Laboratory Medicine, Department of Clinical Pharmacology.
    Spigset, Olav
    Hägg, Staffan
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Clinical Pharmacology. Östergötlands Läns Landsting, Centre for Laboratory Medicine, Department of Clinical Pharmacology.
    Spontaneously reported fatal adverse drug reactions: a 10-year survey from Sweden2006In: International conference on Pharmacoepdemiology Therapeutic risk management,2006, 2006Conference paper (Other academic)
  • 5.
    Wester, Karin
    et al.
    Linköping University, Department of Medicine and Care, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Jönsson, Anna
    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.
    Spigset, Olav
    St. Olav University Hospital, Trondheim, Norway.
    Hägg, Staffan
    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.
    Spontaneously reported fatal suspected adverse drug reactions: A 10-year survey from Sweden2007In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 16, no 2, p. 173-180Article in journal (Refereed)
    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.

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