Adverse drug reactions in Type 2 diabetes mellitus patients on oral antidiabetic drugs in a diabetes outpatient department of a tertiary care teaching hospital in the Eastern India

Abstract

The prevalence of diabetes has been reported to be rapidly increasing in both rural and urban India. [2] An oral antidiabetic drug (OAD) is the first line of drug treatment for Type 2 diabetes. However, the progressive nature of Type 2 diabetes usually requires a combination of two or more oral agents in the long term. Safety and tolerability often limit the optimal use of OADs. [3] According to the World Health Organization (WHO), an adverse drug reaction (ADR) is defined as "a noxious, unintended, and undesirable effect that occurs as a result Research Article Background: Diabetes mellitus is a major healthcare problem in India. Pharmacovigilance of antidiabetic drugs is crucial in detecting adverse drug reactions (ADRs)and providing feedback to physicians on their possibility. In India, few reports are available on the ADR profile of antidiabetic agents. Objectives: This study aims to detect frequency and total burden of different ADRs due to oral antidiabetic drug (OAD)use in a diabetes outpatient in a medical college in Eastern India. Materials and Methods: An observational study was conducted on Type 2 diabetes mellitus patients on oral antidiabetic agents, attending Diabetes Clinic of a Tertiary Care Teaching Hospital in West Bengal between April and September 2013. Details of adverse event history, history of medication suspected of having caused the ADR were recorded in the format followed in the Pharmacovigilance Programme of India. The causality relationship was assessed by the World Health Organization-Uppsala Monitoring Centre criteria. Results: A total of 1000 patients were screened, of which 276 were suspected of having at least one ADR. On causality assessment, 43 of these 276 cases had insufficient evidence about causality and were excluded from the analysis. Out of the remaining 233 patients, 275 suspected ADRs were detected. Among them, metformin contributed 51% of total ADR reported, in the form of dyspepsia and diarrhea, followed by glimepiride-induced hypoglycemia. Vogliboseinduced dyspepsia, pioglitazone-induced pedal edema were also common. Conclusions: ADRs due to OADs is a frequent problem. Few multicentric studies are needed for a strong antidiabetic drug ADR database in India.

A Study on Adverse Drug Reactions and Their Risk Factors of Anti- Asthmatic Agents Among Garments Dust-Induced Asthmatic Patients in Manchester of South India

“…There were no serious events recorded, may be due to insulin was kept out of the measurement, which is the most common agent to cause fatal seizures. Most of the adverse events were managed by reducing the dose of the drug, and in some cases by stopping the drug such as stopping beclomethasone if patients had prolonged palpitation [15]. Adverse effects can perhaps also be reduced using less medication and with adequate knowledge of drug interactions.…”

Studi Prospektif Adverse Drug Reactions (ADRS) Obat Hipoglikemik Oral Terhadap Pasien Diabetes Mellitus Tipe 2 di Suatu Rumah Sakit, Padang

“…Selain itu didapatkan data bahwa Glimepiride atau kombinasi dengan metformin menyebabkan beberapa kejadian hipoglikemia, semuanya terjadi jika glimepirid digunakan dengan dosis 2 mg/hari atau lebih. Dispepsia dan diare adalah efek samping yang paling umum dilaporkan oleh pasien ke dokter terutama karena metformin [7]. Penelitian di Indonesia juga melaporkan terapi obat hipoglikemik oral berupa glibenklamid dan chlorpropramid melaporkan mengalami rasa mual, muntah serta kesemutan pada kaki, dari hasil analisis yang dilakukan peneliti diduga kuat penyebab obat penyebab rasa mual, muntah dan kesemutan adalah glibenklamid [8] dan penelitian lainnya melaporkan kombinasi metformin dan glibenklamid, salah satu pasien tersebut mengalami susah buang air besar [9].…”

Diabetes mellitus increases risk of adverse drug reactions and death in hospitalised older people: the SENATOR trial

“…A few studies from low-and-middle-income countries have reported ADRs in the diabetic population in the hospital setting [19][20][21][22][23]. However, those studies were focused mainly on ADRs due to anti-diabetic medications or reported ADRs as part of drug-therapy problems (DTPs) in diabetes and were methodologically weak with most being observational studies.…”