Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Safety of Oral Paracetamol - Analysis of Data from a Spontaneous Reporting System in Poland

Stanisław Han¹, Ernest Kuchar² , Katarzyna Karłowicz-Bodalska¹, Elzbieta Kutycka³, Katarzyna Miskiewicz², Aneta Nitsch-Osuch⁴

¹Department of Industrial Pharmacy, Wroclaw Medical University; ²Department of Pediatric Infectious Diseases, Wroclaw Medical University; ³Pharmacovigilance Department, PPF Hasco-Lek S.A. Wroclaw; ⁴Department of Family Medicine, Warsaw Medical University, Warsaw, Poland.

For correspondence:- Ernest Kuchar Email: ernest.kuchar@gmail.com Tel:+48717703156

Received: 16 October 2013 Accepted: 16 Macrh 2014 Published: 23 April 2014

Citation: Han S, Kuchar E, Karłowicz-Bodalska K, Kutycka E, Miskiewicz K, Nitsch-Osuch A. Safety of Oral Paracetamol - Analysis of Data from a Spontaneous Reporting System in Poland. Trop J Pharm Res 2014; 13(4):617-620 doi: 10.4314/tjpr.v13i4.20

© 2014 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: To determine the safety of oral coated paracetamol tablets 500 mg and oral suspension 120 mg/5 mL produced by Hasco-Lek Poland.

Methods: We analyzed sales volume and data obtained from the monitoring of spontaneous reports on the adverse effects of paracetamol collected in the period between November 2000 and June 2012.

Results: A total of 45,694 units of coated paracetamol tablets (500 mg) and 6,048,289 units of paracetamol oral suspension (120 mg/5 mL) were marketed during that period. There were 4 spontaneous reports of adverse effects.

Conclusion: Oral paracetamol is a safe medication rarely causing adverse effects but it is possible that the existing spontaneous monitoring system for adverse effects in Poland is not sensitive enough to detect all adverse effects, and needs improvement.

Keywords: Adverse reaction, NSAIDs, Pharmacovigillance, Pharmoepidemiology