uu.seUppsala University Publications
Change search
ReferencesLink to record
Permanent link

Direct link
Hyponatremia in relation to treatment with antidepressants: a survey of reports in the World Health Organization data base for spontaneous reporting of adverse drug reactions
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
1997 (English)In: Pharmacotherapy, ISSN 0277-0008, Vol. 17, no 2, 348-352 p.Article in journal (Refereed) Published
Abstract [en]

To determine the risk factors associated with the development of hyponatremia during treatment with antidepressant drugs, we conducted a retrospective register study of the World Health Organization (WHO) data base for spontaneous reporting of adverse drug reactions. From the start of the WHO Collaborating Centre for International Drug Monitoring in 1968 until the end of 1993, 668 reports of antidepressant-associated hyponatremia disorders were submitted. Seventy-eight percent of them concerned women, compared with 69% for all other adverse drug reactions with antidepressants (p < 0.0005). The mean age of all patients was 66.6 years, compared with 48.6 years for the other adverse drug reactions (p < 0.0001). In 51.3% of the patients the reaction occurred within the first 2 weeks of treatment. Significantly more cases occurred during the summer than during the other seasons (p < 0.02). The risk for hyponatremia during treatment with antidepressants seems to be highest in women, in the elderly, during the summer, and during the first weeks of treatment.

Place, publisher, year, edition, pages
1997. Vol. 17, no 2, 348-352 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-93241PubMedID: 9085327OAI: oai:DiVA.org:uu-93241DiVA: diva2:166666
Available from: 2005-06-02 Created: 2005-06-02 Last updated: 2010-03-04Bibliographically approved
In thesis
1. Hazards of Drug Therapy: On the Management of Adverse Drug Reactions: From Signal Detection and Evaluation to Risk Minimization
Open this publication in new window or tab >>Hazards of Drug Therapy: On the Management of Adverse Drug Reactions: From Signal Detection and Evaluation to Risk Minimization
2005 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Spontaneous reporting systems (SRSs) for adverse drug reactions (ADRs) have been developed as a result of the thalidomide disaster, whereby thousands of children world-wide were born with birth defects. The Swedish Adverse Drug Reactions Advisory Committee was established in 1965. Since 1975, reporting has been compulsory for all suspected serious or new ADRs. International collaboration started in 1968 with countries contributing their ADR reports to an international database set up by the World Health Organization.

ADRs represent the negative side of the benefit-to-risk balance that in theory needs to be counteracted by perceived or established positive drug effects. All drugs are subject to preclinical and clinical testing prior to marketing authorization. However, these studies are insufficient to detect rare ADRs, ADRs that occur after long-term administration or with latency, ADRs that occur in special patient groups such as children, the elderly, patients with renal or hepatic insufficiency or patients on concomitant drug treatment, and ADRs that represent a modest increase in the risk of diseases (including mortality) that are prevalent in the study population. Postmarketing surveillance of drugs is therefore essential, and regulatory action may be needed on the basis of new ADR information.

SRSs are important sources of ADR information as exemplified here by the evaluation of peripheral sensory disturbances with fluoroquinolones, hyponatremia with antidepressants, blood dyscrasias with dipyrone, glucose intolerance with atypical antipsychotics, pulmonary embolism with combined oral contraceptives and extrapyramidal symptoms with selective serotonin reuptake inhibitors. SRSs can be used to study clinical manifestations of ADRs (that can give insights into potential ADR mechanisms), risk factors for the ADR or for specific outcomes of the ADR, and ADR reporting incidences when combined with sales data. Signals from SRSs may need to be studied further e.g., by use of large-scale epidemiologic studies based on record linkage between drug prescription databases and health databases. Owing to the rapid availability of information, however, SRSs are likely to remain of major importance for the post-marketing surveillance of drugs.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2005. 86 p.
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 54
Pharmacology, adverse drug reactions, spontaneous reporting systems, drug regulation, pharmacovigilance, incidence, Farmakologi
National Category
Pharmacology and Toxicology
urn:nbn:se:uu:diva-5866 (URN)91-554-6291-X (ISBN)
Public defence
2005-09-16, Enghoffsalen, Ingång 50, Akademiska sjukhuset, Uppsala, 09:15
Available from: 2005-06-02 Created: 2005-06-02Bibliographically approved

Open Access in DiVA

No full text

By organisation
Department of Medical Sciences
In the same journal
Medical and Health Sciences

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 205 hits
ReferencesLink to record
Permanent link

Direct link