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Nervous system conditions and treatments

Session: Poster Session A

(316) Potential Association of Syndrome of Inappropriate Antidiuretic Hormone Secretion with Olanzapine Use

Monday, August 26, 2024
8:00 AM – 6:00 PM CEST
Location: Convention Hall II

    Presenting Author(s)

  • SA

    Shahad AlNasser, PharmD, MSc, CPHQ

    Drug Safety Expert I
    Saudi Food and Drug Authority, Saudi Arabia

    • Co-Author(s)

  • SA

    Solaiman Alhawas

    Saudi Food & Drug Authority (SFDA), Saudi Arabia

  • NA

    Nouf Al-Fadel, MSc. Clin

    Head of Pharmacoepidemiology Section
    Drug Safety and Risk Management department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
    Riyadh, Saudi Arabia

  • Fawaz Alharbi, MSc, PhD

    Director Of Drug Safety and Risk Management
    Drug Safety and Risk Management department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Saudi Arabia

Background: Olanzapine is an atypical Antipsychotic (AP) approved by Saudi Food & Drug Authority (SFDA) for the treatment of schizophrenia, moderate to severe manic episode, and for the prevention of recurrence of manic episode in patients with bipolar disorder.

Objectives: To evaluate the potential association of Olanzapine with the risk of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) or hyponatremia as a part of class effect project conducted by SFDA.

Methods: We conducted a systematic literature search on January 2024, using several search engines, including PubMed, Embase, and Google Scholar for English studies on human investigating the association between Olanzapine and the risk of SIADH or hyponatremia. The search terms included (‘atypical APs’ OR ‘Olanzapine’ OR ‘Zyprexa’) AND (‘hyponatremia’ OR ‘SIADH’). Moreover, a search was conducted in the World Health Organization (WHO) database “VigiBase” and in the local database of National Pharmacovigilance Center (NPC) to retrieve case reports up to January 2024. Then, the causality assessment of the cases was performed using the WHO-Uppsala Monitoring Center causality system.

Results: A total of 12 observational studies were identified. A significant association between atypical APs and hospitalization due to hyponatremia was reported in a case-control study (adjusted odds ratio: 1.32 [95% confidence interval (CI): 1.15–1.51]) and cohort (absolute risk increased by 0.06 % (95%CI: 0.02 to 0.10 %)) studies, one of which proposed SIADH effect. In addition, 9 published cases reported probable (N=1) and possible (N=8) association of Olanzapine with hyponatremia, 7 of which reported hyponatremia secondary to diagnosed SIADH. In VigiBase, 448 global cases were reported and 20 cases with the highest completeness score (CS) were assessed (CS=1); 6 were probably related, 7 possibly related, and 7 unlikely. No local cases were reported to the SFDA.

Conclusions: The available evidence suggests potential association of hyponatremia secondary to diagnosed SIADH with Olanzapine use. Further epidemiological studies are needed to investigate this potential association.