Adverse drug reactions to selegiline: A review of the French Pharmacovigilance Database

Citation
Jl. Montastruc et al., Adverse drug reactions to selegiline: A review of the French Pharmacovigilance Database, CLIN NEUROP, 23(5), 2000, pp. 271-275
Citations number
25
Categorie Soggetti
Neurosciences & Behavoir
Journal title
CLINICAL NEUROPHARMACOLOGY
ISSN journal
03625664 → ACNP
Volume
23
Issue
5
Year of publication
2000
Pages
271 - 275
Database
ISI
SICI code
0362-5664(200009/10)23:5<271:ADRTSA>2.0.ZU;2-P
Abstract
The present pharmacoepidemiologic study was performed to characterize the p rofile of adverse drug reactions (ADRs) reported with selegiline, a monoami ne oxidase B (MAO-B) inhibitor used in the treatment of Parkinson's disease and previously reported to induce an excess of mortality. The analysis was performed with use of the French Pharmacovigilance Database between 1989 a nd 1997. This database includes all ADRs reported by French practitioners l and especially "serious" and "unexpected" ADRs). Three different analyses w ere performed: identification of ADRs reported with selegiline, comparison with the ADR profile observed with other antiparkinsonian drugs, and a case /non-case study investigating the occurrence of cardiovascular ADRs with se legiline in comparison with other drugs in general and other antiparkinsoni an drugs (e.g., levodopa [L-Dopa], dopamine agonists) in particular. The mo st often reported ADRs with selegiline were psychiatric (delirium, hallucin ations, agitations), cardiovascular (orthostatic hypotension, arterial hype rtension, etc.) and neurologic (sedation, abnormal movements, etc.). Psychi atric and cardiovascular ADRs were more frequently reported with selegiline than with L-Dopa or dopamine agonists. The case/ non-case study found an i ncreased risk of cardiovascular ADRs (OR = 1.72; 95% Ct = 1.16-2.55) when s elegiline was associated with L-Dopa. These data show that the profile of s elegiline-induced ADRs differs from that of other antiparkinsonian drugs (L -Dopa, dopamine agonists) with more psychiatric and cardiovascular ADRs. We suggest that the higher frequency of cardiovascular ADRs could explain, at least partially, the previously reported increase in mortality rate.