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

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