Drug-induced gingival overgrowth: a study in the French Pharmacovigilance Database

Background Gingival overgrowth is an adverse drug reaction (ADR) well known with phenytoin, cyclosporine or calcium channel blockers but can be related to other drugs. Aim We reviewed spontaneous notifications of drug-induced gingival overgrowth (DIGO), in France. Material & methods We selected DIGO cases registered in the French Pharmacovigilance Database, between 1984 and 2010. Results We found 147 DIGO cases (0.04% of all cases), most of them (86.4%) non serious. Patients were more frequently men (58.5%) and between 40 and 69 similar to years (58.5%). Evolution was favourable in 47.5% of cases. The most frequently suspected drugs were calcium channel blockers (30.6%) followed by immunosuppressants (15.2%) and anticonvulsants (10.1%). The DIGO was also reported with drugs for which the ADR was unlabelled (mycophenolate mofetil, valproic acid, clarithromycin, ethynylestradiol, levonorgestrel, desogestrel, etc.). There were two peaks of occurrence (03 and >12 similar to months) for immunosuppressants or calcium channel blockers and only one (>12 similar to months) for anticonvulsants. Conclusion Gingival overgrowth is often a non serious ADR but evolution was favourable in only half of cases. This ADR is labelled for calcium channel blockers, cyclosporine and phenytoin but can also occur with other immunosuppressants or anticonvulsants, antibiotics, oral contraceptives, etc.