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Original Research Article | OPEN ACCESS

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

Stanisław Han1, Katarzyna Karłowicz-Bodalska1, Katarzyna Mi"7;kiewicz2, Elzbieta Kutycka3, Ernest Kuchar2 ,

For correspondence:-  Ernest Kuchar   Email: ernest.kuchar@gmail.com   Tel:+48717703150

Received: 11 October 2013        Accepted: 23 June 2014        Published: 15 December 2014

Citation: Han S, Karłowicz-Bodalska K, Mi"7;kiewicz K, Kutycka E, Kuchar E, Safety of Oral Clemastine - Analysis of Data from Spontaneous Reporting System in Poland. Trop J Pharm Res 2014; 13(12):2115-2118 doi: 10.4314/tjpr.v13i12.24

© 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 analyse the safety of oral clemastine marketed in Poland based on spontaneous adverse event reporting system.
Methods: We analyzed sales volume and data obtained from the monitoring of spontaneous reports on the adverse effects of Clemastinum Hasco tablets (1.0 mg) and Clemastinum Hasco syrup (0.1 mg/mL) received by the manufacturer (PPF HASCO-LEK S.A. Wroclaw, Poland) and National Monitoring Centre in Warsaw in the period January 2007 to June 2012. The Polish system is mainly based on written reports voluntarily submitted by healthcare professionals.
Results: A total of 2,089,717 units of Clemastinum Hasco tablets 1.0 mg and 1,965,340 units of Clemastinum Hasco syrup 0.1 mg/mL were marketed during the period analyzed. Only one spontaneous report on clemastine was registered in the period analyzed.
Conclusion: Oral clemastine is a safe medication, rarely causing adverse effects; Nevertheless, the existing spontaneous monitoring system for adverse effects in Poland may not be sensitive enough and therefore, needs improvement.

Keywords: Clemastine, Adverse drug reactions, Pharmoepidemiology, Drug safety, Pharmacovigilance, Reporting system

Impact Factor
Thompson Reuters (ISI): 0.6 (2023)
H-5 index (Google Scholar): 49 (2023)

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