Drug-induced gingival diseases: insights from the FDA Adverse Event Reporting System (FAERS) database analysis

Area of Science:

• Pharmacovigilance
• Dental Medicine
• Drug Safety

Background:

• Drug-induced gingival diseases represent a significant clinical challenge.
• Understanding the association between medications and gingival health is crucial for patient care.

Purpose of the Study:

• To identify potential drug associations with gingival diseases using the FDA Adverse Event Reporting System (FAERS) database.
• To detect safety signals for medications linked to gingival adverse events.

Main Methods:

• Analysis of FAERS data from 2004Q1 to 2024Q3.
• Application of disproportionality analyses (ROR, PRR, BCPNN, MGPS) to detect adverse event signals.
• Descriptive statistical analysis of patient demographics and reporting sources.

Main Results:

• 34,354 adverse events related to drug-induced gingival diseases were reported.
• 83 drugs exhibited positive risk signals, including anti-osteoporotic agents (zoledronic acid, denosumab, alendronic acid) and cardiovascular drugs (amlodipine, rivaroxaban).
• Females and older individuals were more frequently affected; consumers were the primary reporters.

Conclusions:

• The FAERS database analysis identified specific drugs associated with an increased risk of gingival diseases.
• Findings highlight potential under-documentation of gingival risks for certain medications.
• Results can enhance healthcare providers' ability to recognize and manage drug-induced gingival diseases.