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.