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Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
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Variations between package inserts regarding gingival overgrowth causing drugs.

Philipp Friedrich Georg Ried1, Roland Seifert2

  • 1Institute of Pharmacology, Hannover Medical School, Carl-Neuberg-Str. 1, D-30625, Hannover, Germany.

Naunyn-Schmiedeberg'S Archives of Pharmacology
|November 27, 2025
PubMed
Summary

Drug-induced gingival overgrowth (DIGO) is a significant adverse drug reaction. Valproic acid therapy poses the highest DIGO risk, despite lower prescription rates, necessitating careful patient monitoring.

Keywords:
Adverse drug reactionAnticonvulsantsCalcium channel blockersDIGODrug-induced gingival overgrowthImmunosuppressantsPackage inserts

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Area of Science:

  • Pharmacology and Dentistry
  • Adverse Drug Reactions
  • Drug Safety Monitoring

Background:

  • Drug-induced gingival overgrowth (DIGO) is a common adverse drug reaction associated with high-prescription medications like calcium channel blockers, anticonvulsants, and immunosuppressants.
  • Variability in reported adverse drug reaction (ADR) frequencies exists across drug package inserts (PIs) and Summary of Product Characteristics (SmPCs).

Purpose of the Study:

  • To compare the risk of DIGO across different drug classes and identify specific drugs with the highest propensity for inducing this condition.
  • To analyze and compare the information regarding DIGO in PIs and SmPCs from various manufacturers.
  • To estimate the annual incidence of DIGO in Germany based on prescription data and reported prevalences.

Main Methods:

  • Comparative analysis of drug classes known to cause DIGO (calcium channel blockers, anticonvulsants, immunosuppressants).
  • Evaluation of PIs and SmPCs for discrepancies and completeness regarding DIGO information.
  • Model calculation using 2023 German drug prescription data (Arzneiverordnungsreport) and PI prevalences to estimate DIGO incidence.

Main Results:

  • Significant variations in reported DIGO frequencies and ADRs were observed among different drug package inserts.
  • Summary of Product Characteristics (SmPCs) often provide less detailed or less accurate information on DIGO compared to PIs.
  • Long-term valproic acid therapy was associated with the highest DIGO rate, exceeding that of more frequently prescribed drugs like amlodipine or phenytoin.

Conclusions:

  • Package inserts and SmPCs exhibit inconsistencies in reporting DIGO, impacting healthcare professional information.
  • Valproic acid poses a substantial risk for DIGO, requiring vigilant monitoring in patients undergoing long-term treatment.
  • Early detection and intervention are crucial for managing DIGO, particularly in patients on valproic acid therapy.