Pharmacovigilance through Clinical Observation: Case Series of Drug-Related Oral Lesions and Reactions

The Pharmacovigilance Program of India (PvPI) includes a sensitization program focused on the adverse effects of not only medications but also materials used in medical and dental diagnosis and therapeutics under the Materiovigilance Program of India (MvPI). The oral cavity could be significantly affected by the adverse effects of both medicines and dental materials. Consequently, dental professionals are more involved in reporting and studying the adverse effects that occur in the oral cavity. Since many lesions caused by these adverse effects can mimic other oral conditions, it was essential to report these cases and closely monitor de-challenges and re-challenges to draw accurate conclusions. This series highlighted 15 cases of oral lesions resulting from adverse drug and material reactions that were documented at the Department of Oral Medicine. These cases were duly reported under both the PvPI and MvPI.