Muthiah Palaniappan1, Sureshkumar Srinivasamurthy2, Biswajit Dubashi3, Adithan Chandrasekaran4. 1. Technical Associate - Pharmacovigilance, Department of Clinical Pharmacology, JIPMER , Pondicherry, India . 2. D.M., Department of Clinical Pharmacology, JIPMER , Pondicherry, India . 3. Assistant Professor, Department of Medical Oncology, JIPMER , Pondicherry, India . 4. Head of the Department, Department of Clinical Pharmacology, JIPMER , Pondicherry, India .
Abstract
BACKGROUND: Palmar plantar erythrodysesthesia (PPE) is a dose limiting toxicity of anticancer agents. In some cases it may mandate for discontinuation of anticancer agents. Evaluation of data of PPE among reported adverse drug reactions (ADRs) from the Department of Medical Oncology could quantify the burden. AIM: To evaluate and analyse the PPE among reported ADRs from medical Oncology. MATERIALS AND METHODS: The data of all cases of reported PPE were collected during January 2012 to September 2013 and were analysed with WHO causality assessment scale. The severity was clinically graded. The follow-up data regarding outcome of ADRs were also noted. RESULTS: During the study period of 21 months a total of 1418 ADRs have been reported from 1076 patients. Among them PPE was reported from 31 cases (2.9%). Majority (32.2%) of these patients were on chemotherapy for breast cancer. Patient's age ranged from 17 to 68 y and the median age was 50 y. There were 18 female (58%) and 13 male patients (42%). Capecitabine was the leading drug involved in PPE, reported with 20 cases (64.5%), and followed by docetaxel with 5 cases (16.1%). Majority (67.7%) of the reactions was categorized as certain and 64.5% was grade II severity clinically. CONCLUSION: Our findings show that PPE accounts for 2.9% of total reported ADRs from Medical Oncology during 21 months. Majority of the reactions were classified as certain. Capecitabine is commonly implicated drug.
BACKGROUND:Palmar plantar erythrodysesthesia (PPE) is a dose limiting toxicity of anticancer agents. In some cases it may mandate for discontinuation of anticancer agents. Evaluation of data of PPE among reported adverse drug reactions (ADRs) from the Department of Medical Oncology could quantify the burden. AIM: To evaluate and analyse the PPE among reported ADRs from medical Oncology. MATERIALS AND METHODS: The data of all cases of reported PPE were collected during January 2012 to September 2013 and were analysed with WHO causality assessment scale. The severity was clinically graded. The follow-up data regarding outcome of ADRs were also noted. RESULTS: During the study period of 21 months a total of 1418 ADRs have been reported from 1076 patients. Among them PPE was reported from 31 cases (2.9%). Majority (32.2%) of these patients were on chemotherapy for breast cancer. Patient's age ranged from 17 to 68 y and the median age was 50 y. There were 18 female (58%) and 13 male patients (42%). Capecitabine was the leading drug involved in PPE, reported with 20 cases (64.5%), and followed by docetaxel with 5 cases (16.1%). Majority (67.7%) of the reactions was categorized as certain and 64.5% was grade II severity clinically. CONCLUSION: Our findings show that PPE accounts for 2.9% of total reported ADRs from Medical Oncology during 21 months. Majority of the reactions were classified as certain. Capecitabine is commonly implicated drug.
Entities:
Keywords:
Adverse drug reaction; Anticancer drugs; Hand foot syndrome; Palmar plantar erythrodysesthesia; Pharmacoepidemiology; Pharmacovigilance
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