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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a study of 49 patients identified on 28 October 2017 from the WHO global ADR database [VigiBase], six patients were described, who developed depression, depressed mood, anxiety, dyspepsia, suicidal ideation, thoughts of self-harm or abnormal crying during treatment with desloratadine [routes not stated].
Case 1: A 42-year-old man developed depressed mood during treatment with desloratadine for hay fever. The man started receiving treatment with desloratadine 5mg two times a day. He developed depressed mood 12 hours after the administration of desloratadine. Consequently, desloratadine was stopped. Following the discontinuation, his depressed mood recovered. However, he again developed depressed mood following the re-administration of desloratadine [final outcome not...
- Boer J, et al. Desloratadine and depression, a drug safety signal based on worldwide spontaneous reporting of side effects. Upsala Journal of Medical Sciences 123: 174-178, No. 3, Sep 2018. Available from: URL: http://doi.org/10.1080/03009734.2018.1489918 - NetherlandsCrossRefPubMedPubMedCentralGoogle Scholar