Background: Taste and olfactory disorders are among the rare and generally transient adverse effects of antibiotic therapy. Macrolides are generally not listed among drugs causing taste and olfactive disorders, but one of them or both are described in SPC of some macrolides. The information in literature are isolated and indefinite with respect the nature and the intensity of these manifestations; few and transient cases are described. Objective: To analyse the association between alterations of taste and smell and macrolides in a spontaneous reporting database. Methods: The Italian Interregional Group of Pharmacovigilance (GIF) database holds reports of suspected ADRs submitted by six Italian Pharmacovigilance Regional Centers. In the GIF database all reports of suspected ADRs are classified according to the WHO criteria for causality assessment. The reactions are coded according to the WHO Adverse Reaction Terminology (WHO-ART) and classified as serious or non-serious events on the basis of the WHO Critical Term List. Quantitative analysis of database is regularly performed twice a year applying the Proportional Reporting Ratio (PRR) methodology. Moreover qualitative case-by-case analysis is currently performed and follow-up of signals of interest is carried out. Results: GIF databases actually holds 39.887 reports of ADRs, 126 of them, referring smell and taste disorders (0.3 % of total reports). A signal of alterations of smell and taste in association with macrolides therapy came out from quantitative GIF database analysis in 2005. Clarithomycin seems to be involved more frequently than other macrolides as shown in the table I. Table I. Taste and smell alteration reports in association with macrolides in GIF database as of December 2005 Drug Taste disorders Smell disorders Taste and smell disorders Azithromycin 1 1 Clarithromycin 11 1 6 Roxithromycin 1 1 The loss of taste and/or smell was complete in many patients and in some of them persisted after three years from the onset, as resulted by a follow-up of cases, carried out by calling telephonically the physicians. Conclusion: Taste and smell disturbances can be associated with clarithromicin and other macrolides. In some patients a complete loss of both taste and smell persists for years or becomes permanent, strongly affecting the quality of life. The knowledge and prompt identification of these ADRs by patients and physicians can allow to suspend the drug and to avoid heavy consequences.
Transient and Permanent taste and Smell Disorders Associated with Clarithromycin and Other Macrolides in GIF Database
Magro, Lara;
2006-01-01
Abstract
Background: Taste and olfactory disorders are among the rare and generally transient adverse effects of antibiotic therapy. Macrolides are generally not listed among drugs causing taste and olfactive disorders, but one of them or both are described in SPC of some macrolides. The information in literature are isolated and indefinite with respect the nature and the intensity of these manifestations; few and transient cases are described. Objective: To analyse the association between alterations of taste and smell and macrolides in a spontaneous reporting database. Methods: The Italian Interregional Group of Pharmacovigilance (GIF) database holds reports of suspected ADRs submitted by six Italian Pharmacovigilance Regional Centers. In the GIF database all reports of suspected ADRs are classified according to the WHO criteria for causality assessment. The reactions are coded according to the WHO Adverse Reaction Terminology (WHO-ART) and classified as serious or non-serious events on the basis of the WHO Critical Term List. Quantitative analysis of database is regularly performed twice a year applying the Proportional Reporting Ratio (PRR) methodology. Moreover qualitative case-by-case analysis is currently performed and follow-up of signals of interest is carried out. Results: GIF databases actually holds 39.887 reports of ADRs, 126 of them, referring smell and taste disorders (0.3 % of total reports). A signal of alterations of smell and taste in association with macrolides therapy came out from quantitative GIF database analysis in 2005. Clarithomycin seems to be involved more frequently than other macrolides as shown in the table I. Table I. Taste and smell alteration reports in association with macrolides in GIF database as of December 2005 Drug Taste disorders Smell disorders Taste and smell disorders Azithromycin 1 1 Clarithromycin 11 1 6 Roxithromycin 1 1 The loss of taste and/or smell was complete in many patients and in some of them persisted after three years from the onset, as resulted by a follow-up of cases, carried out by calling telephonically the physicians. Conclusion: Taste and smell disturbances can be associated with clarithromicin and other macrolides. In some patients a complete loss of both taste and smell persists for years or becomes permanent, strongly affecting the quality of life. The knowledge and prompt identification of these ADRs by patients and physicians can allow to suspend the drug and to avoid heavy consequences.
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