Drug-induced gingival hyperplasia: a retrospective study using spontaneous reporting system databases.

Area of Science:

• Pharmacovigilance
• Drug Safety
• Oral Health

Background:

• Drug-induced gingival hyperplasia (DIGH) negatively impacts chewing, aesthetics, pronunciation, and quality of life (QOL).
• Evaluating DIGH incidence through spontaneous reporting systems (SRS) is essential for patient safety.

Purpose of the Study:

• To assess the incidence of drug-induced gingival hyperplasia (DIGH).
• To identify drugs associated with DIGH using spontaneous reporting system (SRS) databases.

Main Methods:

• Analysis of DIGH reports from FDA FAERS and Japanese JADER databases.
• Calculation of reporting odds ratios (RORs) for immunosuppressants, calcium channel blockers, and anticonvulsants.
• Evaluation of time-to-onset and hazard type using Weibull shape parameter (WSP) and association rule mining.

Main Results:

• High RORs observed for amlodipine, phenytoin, clobazam, and mycophenolate mofetil.
• Median time-to-onset for DIGH was 71 days (immunosuppressants), 262 days (calcium channel blockers), and 37 days (anticonvulsants).
• Anticonvulsants exhibited a wear-out failure type hazard, indicating increased risk over time.

Conclusions:

• Monitoring patients on immunosuppressants, calcium channel blockers, and anticonvulsants for DIGH is critical.
• Long-term use of calcium channel blockers (approx. 260 days) poses a significant DIGH risk.
• Patients with intellectual disability on phenytoin require careful monitoring for DIGH.