Safety of Oral Paracetamol
– Analysis of Data from a Spontaneous Reporting System
in Poland
Stanisław Han1,
Ernest Kuchar2*, Katarzyna Karłowicz-Bodalska1,
Elżbieta Kutycka3, Katarzyna Miśkiewicz2
and 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:
Email:
ernest.kuchar@gmail.com; Tel:
+48717703156
Received: 16 October 2013
Revised accepted: 16 Macrh
2014
Tropical
Journal of Pharmaceutical Research, April 2014;
13(4):
617-620
http://dx.doi.org/10.4314/tjpr.v13i4.20
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
