Diclofenac (voltaren:Voltarol)-Associated hepatotoxicity

The television report on Cable News Network (CNN) on 9 August 1993 on the exceptionally large numbers of reports in the USA of hepatitis and jaundice associated with intake of diclofenac leading, in an appreciable number of cases, to death is indeed of much concern. All kinds of issues are raised, namely: (a) How many reports of adverse drug reactions (ADRs) are necessary before action should be taken? (b) What is the nature of action in this case? (c) What are the responsibilities, regarding proper conduct of enquiries and in taking preventive action, of the company marketing the drug, the government regulatory agencies (e.g. Food and Drug Administration (FDA)), and legal-political authorities. (d) Why is so little known about the causes of side-effects, such as hepatotoxicity from NSAIDs, which are not uncommon.