Drug-induced autoimmunity: experience of the French pharmacovigilance system.

Spontaneous reporting of suspected adverse drug reactions to a pharmacovigilance structure is a reasonable tool to detect new associations between drugs and a given toxic effect. An analysis of the French national database of pharmacovigilance was undertaken to evaluate how such a system is relevant to survey and/or detect drug-associated autoimmune disorders. Only 0.2% of reports were coded with terms suggestive of systemic autoimmune diseases. Drugs most frequently found were cardiovascular drugs, antiepileptic drugs and slow-acting anti-inflammatory drugs. Most of reports involved drugs previously recognized as a possible cause of autoimmune disorders. Minocycline or HMG-CoA reductase inhibitors were suggested to be involved in several reports and represented possible new cases of drug-associated autoimmune disorders. In conclusion, drugs are infrequently reported as a cause of systemic autoimmune disorders compared to other adverse drug reactions and may not represent a critical health problem for drug regulatory agencies to deal with.