Adverse event monitoring in patients on newer anti-diabetic drugs of a tertiary care hospital in north india

Background- Adverse event is any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment. The adverse event is called Adverse drug reaction (ADRs) when causality relationship is established with the drug. Prescription event monitoring is a method to know utilization and ADRs of drug. It is important method as the drug under study is consumed by large number of patients and multiple doses, for more than one indication and for longer duration. Despite all efforts, ADR monitoring and reporting activity is stillpoor in India.
Objective- To determine frequency and distribution of adverse drug events in patients on newer anti-diabetic drug therapy.
Material and Methods- This cross sectional observational study was carried out on patients presenting in Endocrinology OPD of a tertiary care hospital in North India for a duration of one and half year i.e. from January, 2014 to June, 2015. Data regarding the patient demographics and ADRs was collected by patient interviews.Causality was assessed by WHO causality assessment scale and Naranjo scale.
Results-A total of 146 ADRs were reported during this duration in 118 patients (58 males, 61 females). Mean age of patients was 54.10 ±9.91 years (Males:51.6 ±9.89 years, Females:56.8 ±10.72 years). The number of ADRs per patient was 1.25. The most common drug leading to ADR was Sitagliptin (35.62%) followed by Glimepiride (34.02%) and Pioglitazone (22.52%) The most common ADR noted was weakness/ fatigue (20.00%) followed by nausea (14.17%) and hypoglycaemia (10.28 %).
Conclusions- The newer anti diabetic drugs cannot be considered as absolutely safe, although the nature of ADRs with these drugs is mild to moderate. We need to monitor these drugs for a longer duration of time and in larger number of patients to be sure of safety profile.