ABSTRACT
Background: Serious adverse drug reactions (ADRs) constitute a major limitation in clinical development of a drug thus necessitating close monitoring. Studies regarding the pattern of serious ADRs are limited in southern India. The present study was conducted in tertiary care hospital in Andhra Pradesh with an objective to evaluate the pattern of severe cutaneous and non-cutaneous ADRs in our hospital and to assess the causality, severity, and preventability of these reactions.Methods: A retrospective observational study was conducted over two years, from January 2016 till January 2018 in our ADR monitoring center. The pattern of serious adverse drug reactions, the nature of ADR, suspected drug, the outcome and preventability were analyzed using Modified Hartwig and Siegel scale, and modified Schumock and Thorton scale.Results: Out of 734 ADRs reported, 42 were serious, while 692 were non-serious. Out of 42, 22 were dermatological in origin while the others were acute kidney injury, acute psychosis, febrile neutropenia, gynecomastia, and lipodystrophy. According to WHO causality assessment scale, 27 were probable while 15 were possible. The majority were reported in the age group of 16 to 65 years with female (34) preponderance. The most common drug category responsible was antimicrobials, followed by antiretrovirals, anti-epileptics, and analgesics.Conclusions: Antimicrobial, anti-epileptics, and analgesics contributed to serious ADRs. Although non-cutaneous ADRs did not result in hospitalization, they caused social inhibition and mental stress in the patient.
ABSTRACT
Background: Prevalence of iron deficiency anaemia is high in developing countries like India. Treatment of iron deficiency anaemia in pregnancy is very important to bring down maternal mortality rate as blood loss during delivery can lead to death of the patient. The aim and objective of our study is to evaluate the efficacy and safety of intravenous iron sucrose infusions in antenatal women admitted in hospital suffering from moderate iron deficiency anaemia. Special emphasis was given to observe adverse drug effects.Methods: This was a prospective observational study conducted in Obstetrics and Gynaecology department, Government General Hospital, Rangaraya Medical College, Kakinada, Andhra Pradesh. Study period was two months and study population included antenatal women with gestational age less than 37 weeks with moderate iron deficiency anaemia. Peripheral smear was examined for microcytic hypochromic anaemia and they were treated with intravenous infusion of iron sucrose. Haemoglobin levels were checked before and 5 weeks after iron infusions. Monitoring was done for adverse reactions.Results: Out of 322 admissions, 95% were found to be anaemic. 72 patients were suffering from moderate anaemia from which 25 have been included and treated with intravenous iron sucrose infusions. They were observed for efficacy and safety parameters. Two minor adverse events were reported (fever with chills and angioedema of lips) and they were excluded from study. Mean haemoglobin concentration was found to be raised from 7.08±0.73 (SD) to 11.33±0.48 (SD) within 5 weeks for 23 patients.Conclusions: Iron sucrose infusion is safe and effective for anaemia in pregnancy.