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Abstract Aim: Adverse Drug Reactions are a global problem. The incidence of oral cancer is 2% worldwide. In India, the higher incidence (30% of all cancers) of oral cancer is due to tobacco, betal chewing and alcohol. Cancer chemotherapy is more helpful in advanced stages of oral cancer. But, these drugs themselves can cause adverse drug reactions affecting the patients’ health. Objective: To study the pattern of adverse drug reactions of anticancer drugs used in patients with oral cancer in a tertiary care hospital. Materials and Methods: This study was conducted in Stanley Medical College Hospital, Chennai-01 from August’2014 to February’2015 among 60 oral cancer patients receiving anticancer drugs in Dept of Oncology. This was a hospital based, prospective, observational study. ADRs were documented in suspected ADR reporting forms designed by CDSCO; causality assessment was done using Naranjo’s algorithm and severity assessment by Modified Hartwig Siegel Scale. Result: Cisplatin, 5-Fluorouracil, Paclitaxel, Gemcitabine were the common anticancer drugs used in various combinations. The most common combinations used are 5FU + Cisplatin, Gemcitabine + Cisplatin, 5FU+ Paclitaxel+Carboplatin. ADRs were reported among 54 patients taking treatment. Causality assessment – Probable 5.6% ,Possible 94.4% ; Severity assessment – Mild 94.4%,Moderate 5.6%. Conclusion: The anticancer drug combinations used in the treatment of oral cancer were associated with varied adverse effects. But, the early detection of drug toxicity may be helpful in modifying the doses to minimize the toxic effects.

Keywords: ADRs, CDSCO, Cisplatin, Tertiary care hospital.

 

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