Adverse drug reaction profile of cisplatin-based chemotherapy regimen in a tertiary care hospital in India: An evaluative study.
OBJECTIVE
This prospective study was designed to monitor and analyze the pattern of occurrence of adverse drug reactions (ADRs) to cisplatin-based chemotherapy regimen in the cancer ward of a tertiary care hospital.


METHODS
Cancer patients who received cisplatin-based cancer chemotherapy were monitored for adverse reactions. The collected reports were analyzed for demographic and drug details, causality, preventability and severity of adverse effects. Causality was assessed by the World Health Organization (WHO) causality assessment scale and Naranjo's Algorithm. Preventability and severity of ADRs were assessed by modified Schumock and Thornton scale, modified Hartwig and Siegel scale respectively.


RESULTS
Among 51 patients, 48 developed ADRs to cisplatin chemotherapy. The reactions observed were nausea, alopecia, anorexia, vomiting, taste alteration, diarrhea, constipation, tinnitus, and hypocalcaemia. The WHO causality assessment scale indicated 69% "possible" and 31% "probable" but no "certain" reactions. Naranjo's Algorithm showed 62% "probable" and 38% "possible" reactions. Most of the reactions belonged to the category of "not preventable". Reactions like nausea and vomiting belonged to the category of "definitely preventable". Modified Hartwig and Siegel scale of severity assessment showed that most of the reactions were of "mild level 1" severity except for vomiting, diarrhea and hypocalcaemia, which were of "moderate level 3" severity.


CONCLUSIONS
Cisplatin-based chemotherapy has a high potential to cause adverse effects. Most of the reactions were of milder nature but not preventable. The common adverse effects such as nausea and vomiting were preventable, but reactions like hypersensitivity reactions and anaphylaxis were not predictable.
Surendiran
A
A
Department of Pharmacology, JIPMER, Pondicherry, India.
Balamurugan
N
N
Gunaseelan
K
K
Akhtar
Shahid
S
Reddy
K S
KS
Adithan
C
C