A clinical pharmacological study of quantitative specific symptomatologyin global anaemic patients, and pharmacovigilance evaluation of ferrous ascorbate supplements

Introduction: Anaemia, especially during adolescence, pregnancy and lactation, is associated with extreme weakness, impaired immune system, preterm delivery, low birth weight, and maternal and perinatal morbidity and mortality. It can be controlled by oral haematinicsupplements like ferrous ascorbate, ferrous fumarate, ferrous sulphate or ferric ammonium citrate which tends to rise the haemoglobin concentration.
Objectives: The objective of this clinical pharmacological study was to assess the quantitative specific symptomatology in global anaemic patients, and a pharmacovigilance safety evaluation of ferrous ascorbate supplements.
Methods: A multi-centre, prospective, open-labelled study on25mild to early moderate grades, global anaemic patients, was performed. The occurrence of specific symptoms among global anaemic patients, that is, weakness and skin pallor, and the detailed specific anaemic symptoms assessment, were recorded and analysed according to their types of occurrences. A pharmacogenomic safety analysis was also conducted, after the treatment of these patients with oral ferrous ascorbate supplements, containing 60 mg of elemental iron, once daily, with meals, for 3 months, in accordance with the followed haematinic treatment regimens, and the respective grades of anaemia, from which the patientswere suffering. The monitoring of adverse drug reactions occurrence, like epigastric pain, heartburn, nausea, vomiting, staining of teeth, metallic taste, bloating, colic, diarrhoea and constipation, was done among the patients, with Adverse Event Case Report Forms, on days 0, 30, 60, 90, and on further follow-ups.
Results: In this study, most of the anaemic patients manifested the specific symptoms of weakness and skin pallor together. The safety assessment showed that the occurrence of adverse effects was statistically non-significant.
Conclusions: Co-existing specific symptomatology of weakness and skin pallor was predominant. Ferrous ascorbate was safe and tolerable among all the anaemic patients.