Australia. In the October issue of the Australian Adverse Drug Reactions Bulletin, the Australian Adverse Drug Reactions Advisory Committee (ADRAC) highlights adverse reactions associated with the antidepressant drug mirtazapine. ADRAC has received a total of 253 adverse drug reaction (ADR) reports associated with mirtazapine, including potentially serious reports of seizures (n = 16) and blood dyscrasias (15). Other mirtazapine-associated ADRs reported to ADRAC include oedema (n = 33), anxiety/agitation (24), myalgia/arthralgia (24), sedation (23) and skin reactions (20). In addition, a prescription event monitoring (PEM) study conducted in England involving over 13 000 patients found drowsiness/sedation and malaise/lassitude to be the most frequent mirtazapine-associated ADRs occurring in 5.8% and 2.8% of patients, respectively. However, although two cases of blood dyscrasias were identified in this study, there were no cases of seizures.

Reference:
Australian Adverse Drug Reactions Bulletin Vol 22, No. 5, October 2003. Available from URL: http://www.health.gov.au/tga