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Acta Medica Medianae
Vol. 50, No 3, September, 2011

UDK 61
ISSN 0365-4478(Printed version)
ISSN 1821-2794(Online)


Correspondence to:

 Vladica Veličković

University of Niš

Faculty of Medicine

Bul. dr Zorana Đinđića br. 81

18000 Niš, Serbia

E-mail: velickovic@inbox.com

Review article                                                                                                     

UDC: 615.065




Potentially dangerous side-effects of drugs and “Black box” warning system


Vladica Veličković1, Aleksandar Višnjić1,2 and Nataša Đinđić1


University of Niš, Faculty of Medicine, Niš, Serbia1

Public Health Institute, Niš, Serbia2


Pharmacovigilance or collecting, monitoring, research, assessment and evaluation of information obtained from the manufacturer, health workers and patients about the adverses of the drugs, biological products, traditional medicines, with the aim to detect new information on the dangers of the drugs as well as prevention of new adverse side-effects harmful for the patients which is obligatory for the regulatory agencies, authorized by the authorities in almost every country. Modern trends of treating the patients in connection with rising number of new drugs in all pharmaceutical forms on the market demand continued improvement of the pharmacovigilance system with the accent on the feedback information towards the final consumers and doctors who prescribe them. One of very efficient communication tools between the regulation agency and final consumers/prescribers is created and implemented by Food and Drug Administration in the USA (FDA) called “boxed warning” – “black box”. “Black box” warnings are the most serious warnings of FDA on the drugs, which point out potentially fatal, life threatening risks, or disabling side-effects of the drugs. It is named for the black border surrounding the text of the warning. The border was designed to draw attention on the warning and to emphasize it in relation to other information as a part of the drug packing. Looking into the studies monitoring the way the drugs with this kind of warning were used showed that explicit, well-publicized warning can change the prescribing habits of doctors and influence the patients to be more careful in using specific drugs or even classes of drugs. Acta Medica Medianae 2011;50(3):69-73.


      Key words: pharmacovigilance, FDA, “Black box” warnings, side-effects