A study on adverse drug reactions related to drug-induced neurotoxicity in Malaysia from 2013 until 2014

Based on the spontaneous adverse drug reactions (ADRs) reported in Malaysia, ADR related to drug-induced nervous system disorders contribute to the third highest cases. The number of ADRs reported was increased by the year. Thus, an action needs to be taken in order to solve this problem. This study was aimed to determine the pattern of neurotoxicity induced by the drug in Malaysia (2013-2014) in terms of a group of age, race, gender, causality assessment and extent of disease severity. Apart from that, this study will determine the predictors that contribute to the most common drug-induced neurotoxicity. This is a retrospective study. The data was collected at Pharmacovigilance Section, National Pharmaceutical Control Bureau (NPCB). The total number of ADRs reports retrieved from Quest 2 database were 1302 reports from the year 2013 until the year 2014. The data of the reports were classified according to the type of neurotoxicity caused by a drug before analyzing it. The female patient was found out to be higher with ADRs reported with 63.4% as compared to the male patient. Most of the patient that were reported with ADR was Malay population with 45.9%. The age group that was highest reported with ADR was the patient between age 46 to 60 years old (32.8%). It has been discovered by using a Pearson chi-square test that there were no association between the gender (P = 0.774), race (P = 0.774) and groups of age (P = 0.510) with the extent of severity. Almost half of the ADR reported were classified to have a probable reaction (44.2%) and have a moderate severity with 46.6%. There were 24 types of neurotoxicity and 1075 ADR cases that have been reported throughout this study. Dizziness was accounted for 60.9% of the total ADR reported related to neurotoxicity. Amlodipine was the highest drug reported to cause neurotoxicity in 118 cases out of 1035 cases. From the simple logistic regression that has been done, there were no predictors (age, gender and race) associated with the increased risk of getting neurotoxicity among the patient. In conclusion, the pattern of neurotoxicity regarding the use of a particular drug in Malaysia (2013-2014) was demonstrated in this study. The amlodipine has been pointed out to be the highest drug reported in inducing neurotoxicity in Malaysia from 2013 until 2014.