Objective: To identify the number of cases of anaphylaxis reported in association with different classes of drugs and compare it with other reports contained in the same database. Methods: The data were obtained from a database containing all of the spontaneous reports of adverse drug reactions (ADRs) coming from the Italian Regions of Emilia Romagna, Lombardy and the Veneto, the main contributors to the Italian spontaneous surveillance system. The ADRs reported between January 1990 and December 2003 with a causality assessment of certainly, probably or possibly drug related (according to the WHO criteria) were analysed using a case/non-case design. The cases were defined as the reactions already coded by the WHO preferred terms of “anaphylactic shock” or “anaphylactoid reaction” (this last term also included anaphylactic reaction), and those with a time of event onset suggesting an allergic reaction and involving at least two of the skin, respiratory, gastrointestinal, cardiovascular or central nervous systems; the non-cases were all of the other ADR reports. The frequency of the association between anaphylaxis and the suspected drug in comparison with the frequency of anaphylaxis associated to all the other drugs was calculated using the ADR reporting odds ratio (ROR) as a measure of disproportionality. Results: Our database contained 744 cases (including 307 cases of anaphylactic shock with 10 deaths) and 27,512 non-cases. The percentage of anaphylaxis cases reported in hospital was higher than that among outpatients (59.1% versus 40.9%). This distribution is significantly different from that of the other ADR reports that mainly refer to outpatients. After intravenous drug administrations, anaphylactic shock cases were more frequent than anaphylactoid reactions or other ADRs, but more than one-third of them was caused by an oral drug. Blood substitutes and radiology contrast agents had the highest RORs. Among the systemic antibacterial agents, anaphylaxis was disproportionally reported more for penicillins, quinolones, cephalosporins and glycopeptides, but diclofenac was the only NSAID with a significant ROR. As a category, vaccines had a significantly lower ROR, thus indicating that anaphylaxis is reported proportionally less than other ADRs.
Drug-induced anaphylaxis: case/non-case study based on an Italian pharmacovigilance database
LEONE, Roberto;CONFORTI, Anita;MORETTI, Ugo;Meneghelli, Ilaria;VELO, Giampaolo
2005-01-01
Abstract
Objective: To identify the number of cases of anaphylaxis reported in association with different classes of drugs and compare it with other reports contained in the same database. Methods: The data were obtained from a database containing all of the spontaneous reports of adverse drug reactions (ADRs) coming from the Italian Regions of Emilia Romagna, Lombardy and the Veneto, the main contributors to the Italian spontaneous surveillance system. The ADRs reported between January 1990 and December 2003 with a causality assessment of certainly, probably or possibly drug related (according to the WHO criteria) were analysed using a case/non-case design. The cases were defined as the reactions already coded by the WHO preferred terms of “anaphylactic shock” or “anaphylactoid reaction” (this last term also included anaphylactic reaction), and those with a time of event onset suggesting an allergic reaction and involving at least two of the skin, respiratory, gastrointestinal, cardiovascular or central nervous systems; the non-cases were all of the other ADR reports. The frequency of the association between anaphylaxis and the suspected drug in comparison with the frequency of anaphylaxis associated to all the other drugs was calculated using the ADR reporting odds ratio (ROR) as a measure of disproportionality. Results: Our database contained 744 cases (including 307 cases of anaphylactic shock with 10 deaths) and 27,512 non-cases. The percentage of anaphylaxis cases reported in hospital was higher than that among outpatients (59.1% versus 40.9%). This distribution is significantly different from that of the other ADR reports that mainly refer to outpatients. After intravenous drug administrations, anaphylactic shock cases were more frequent than anaphylactoid reactions or other ADRs, but more than one-third of them was caused by an oral drug. Blood substitutes and radiology contrast agents had the highest RORs. Among the systemic antibacterial agents, anaphylaxis was disproportionally reported more for penicillins, quinolones, cephalosporins and glycopeptides, but diclofenac was the only NSAID with a significant ROR. As a category, vaccines had a significantly lower ROR, thus indicating that anaphylaxis is reported proportionally less than other ADRs.
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