Performance of the standardised MedDRA® queries for case retrieval in the French spontaneous reporting database.

Objective: The objective of this study was to evaluate the performance of Standardised MedDRA® Queries (SMQs) in adverse drug reaction (ADR) identification.

Methods: ADR cases included in the last complete year of the French Pharmacovigilance database for research were used to test four SMQs (narrow and broad): agranulocytosis, demyelination, osteonecrosis and psychosis. Reference cases were identified by free-text search and validated by two authors.