Drug Safety 2007; 30 (10): 919-990
A BSTRACTS 0114-5916/07/0010-0919/$44.95/0
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Poster Presentations
P.107 The Value of Individual Case Reports: Artificial Colouring in Drugs and the Relationship with Adverse Drug Reactions
A.M.H. Bijl, E.P. van Puijenbroek, A.C. van Grootheest Netherlands Pharmacovigilance Centre Lareb,
‘s-Hertogenbosch, The Netherlands
Background: The Netherlands Pharmacovigilance Centre Lareb received a report of urticaria on blue levothyroxine tablets which resolved after switching to white levothyroxine tablets. For decades, artificial colouring used in medications has been held responsible for a diversity of adverse drug reactions. Sparse evidence is available from controlled studies but some case reports in literature and in spontaneous reporting systems are very suggestive for a causal relationship.
Objective/aim: The aim of this study was to analyse the role of artificial colouring substances in the pathogenesis of adverse drug reactions in spontaneous reports.
Methods: An analysis of the reports submitted to the Netherlands Pharmacovigilance Centre Lareb was conducted, in which a possible role of artificial colouring agents was suspected. In addition, the available literature was reviewed.
Results: On April 1st 2007 the Lareb database contained 30 cases in which the reporter suspected a possible role for an artificial colouring substance in the suspected drug. In the majority of cases a causal relationship could not be proven because alternative explanations for the adverse reaction could not be excluded. In many reports detailed information on the exact composition of the drug formulation that had actually been used was not known. In a number of cases however, the blue dye indigocarmine (E132) could be identified as a possible cause of adverse drug reactions.
Conclusion: In literature, several convincing case reports are available, but there is still debate on the extent to which artificial colouring agents are the cause of adverse drug reactions.
Spontaneous reporting offers an opportunity to retrieve such cases.
Detailed medication history and detailed clinical information is a prerequi- site for revealing a possible role for artificial colouring in the pathogenesis of adverse drug reactions.
Physicians should be aware of the rare possibility of these substances to cause an adverse drug reaction, especially in hypersensitivity reactions, but other causes should be excluded and proper diagnostic procedures should be carried out.
