ADVERSE DRUG REACTIONS (ADRS) OF CISPLATIN IN PULMONARY CANCER PATIENTS- ONE YEAR PROSPECTIVE STUDY

Background: A cross sectional prospective observational study evaluated the trends and patterns of Adverse drug reactions of cisplatin in pulmonary cancer patients .

Methods:Pulmonary cancer patients, who received cisplatin as chemotherapy regimen, were monitored for adverse reactions. New and old diagnosed cases of pulmonary cancer patients belonging to either gender and of all ages, who were receiving cisplatin under any standard regimen, were included for the study. Any ADR due to poisoning, over dosage were excluded from the study. The ADRs were recorded in Central Drugs Standard Control Organization forms. Casuality was assessed by the WHO Casuality Assessment Scale and Naranjos Alograthim.

Results:A total number of 98 patients were reported during the study period, wherein a total number of 114 ADR cases were observed.The majority of patients were in the age group of 61-80 (n=45), followed by 41 -60 years (n=41, 41.83%) .Out of the total ADRs, most frequently reported one was vomiting 18 (15.78%) followed by anemia 16 (14.03%), nausea 13(11.40%) and hair loss 12 (10.52 %) which together constituted 51.73 % of the total ADRs. The other commonly encountered ADRs were diarrhea 8 (7.01%), thrombocytopenia 6 (5.26%), constipation 6 (5.26%) neutropenia 5(4.38) and neuropathy 5(4.38%).According to WHO-UMC scale, 37(37.75%) of reports to be certain,33(33.67%) of reports to be possible and 28(28.57%) of reports to be probable where there was no case recorded as unclassified or inaccessible.Naranjos scale which classified 65 (66.32%) to be probable and remaining 33 (33.67%) to be possible.

Conclusion:Cisplatin has high potential for adverse effects. There is a need to improve the management of adverse effects. This study also emphasizes the need to improve pharmacovigilance awareness among physicians in order to improve the pharmacovigilance in India.