The drug safety program in psychiatry „AMSP“ („Arzneimittelsicherheit in der Psychiatrie“) is a hospital-based independent system of pharmacovigilance. It is reported
on 53.042 of 122.562 patients treated with antidepressants who were monitored from
the year 1993 through 2000 in 35 psychiatric hospitals in German speaking countries.
The overall incidence of severe ADRs of antidepressants was 1,4% of exposed patients;
when only ADRs rated as probable or definite were considered, a rate of 0,9% was observed.
ADR rates were higher for TCA and lower for MAO-inhibitors with ADRs due to SSRI ranging
in between. Dual acting antidepressants venlafaxine and mirtazapine were recently
included in our monitoring process; according to our data it remains unclear whether
any specific SSRI or venlafaxine had a stronger association with the special risk
of hyponatremia; but there is evidence that the risk of mirtazapine is lower.
