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Severe adverse drug
reactions of antidepressants: results of the German multicenter drug
surveillance program AMSP.
Degner D, Grohmann R,
Kropp S, Ruther E, Bender S, Engel RR, Schmidt LG.
Department
of Psychiatry and Psychotherapy, Georg-August University, Goettingen,
Germany.
The goal of the German drug safety program in psychiatry
AMSP (Arzneimittelsicherheit in der Psychiatrie) is the assessment of
severe or new adverse drug reactions (ADRs). Here we report on 53,042 of
122,562 patients treated with antidepressants who were monitored from
1993 to 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 % in patients treated with antidepressants was
observed. ADR rates were higher for TCAs (imputed in 1.0 % of patients
overall, respectively in 0.6 % of patients when only ADs were imputed)
and lower for MAO inhibitors and SSRIs (0.7 % for both, respectively 0.3
% and 0.4 %). Within the TCA group there was a difference among
clomipramine (2.1 %, respectively 1.0 %), amitriptyline (1.0 %,
respectively 0.6 %), and doxepin or trimipramine (both 0.6 %,
respectively 0.3 %). With regard to single SSRI, similar rates were
observed for paroxetine (0.8 %, respectively 0.5 %) and for citalopram
(0.7 %, respectively 0.4 %). Of the new dual-acting antidepressants,
venlafaxine ranged at 0.9 %, (respectively 0.5 %) and mirtazapine at 0.6
% (respectively 0.5 %). In particular, TCAs were associated with known
risks, such as toxic delirium, grand mal seizures, and hepatic (i. e.,
increased liver enzymes), urologic (i. e., urinary retention), allergic
(i. e., exanthema), or cardiovascular (i. e., mainly orthostatic
collapse) reactions. In SSRI-treated patients (non-delirious) psychic
and neurological ADRs were most prominent, followed by gastrointestinal,
dermatologic, and endocrinological/electrolyte reactions, with
agitation, hyponatremia (probably as part of the SIADH syndrome and
associated with severe neurologic or psychiatric symptoms in 64 % of all
cases), increased liver enzymes, nausea, and the serotonin syndrome as
leading unwanted symptoms. Venlafaxine (in the immediate-release
formulation) was associated with adverse CNS and somatic symptoms such
as severe agitation, diarrhea, increased liver enzymes, hypertension,
and hyponatremia. Mirtazapine was mostly connected with increased liver
enzymes, cutaneous edema, and collapse, but with no case of significant
hyponatremia. For drugs that potently inhibit serotonin uptake, serum
sodium concentration should be controlled when applied in high-dose
therapy or in vulnerable patients.
Publication Types:
PMID: 15052513 [PubMed - indexed for
MEDLINE]
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