POTENTIALLY DANGEROUS SIDE-EFFECTS OF DRUGS AND “BLACK BOX” WARNING SYSTEM

• Published in: Acta Medica Medianae Vol. 50; no. 3; pp. 69 - 73
• Main Authors: Vladica Veličković, Aleksandar Višnjić, Nataša Đinđić
• Format: Journal Article
• Language: English
• Published: University in Nis, Faculty of Medicine 15-09-2011
• Subjects: FDA; pharmacovigilance; side-effects; “Black box” warnings
• ISSN: 0365-4478
• DOI: 10.5633/amm.2011.0313

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.