Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions.

OBJECTIVE:We analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions. METHODS:Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary's teaching hospital, Daejeon, Korea) from 2010-2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton's preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed. RESULTS:Of 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p < 0.001), and more likely to be type A reactions (73.5% vs. 18.8%, p < 0.001). Females were over-represented among drug-induced adverse reactions (68.1%, p < 0.001) but not among contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization-Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p < 0.001). CONCLUSIONS:We found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse reactions. The World Health Organization-Uppsala Monitoring Centre and Naranjo algorithm causality evaluation afforded similar results

Characteristics of drug-induced adverse reactions (D-ADRs): causality versus evaluation tools.

<p>WHO-UMC, World Health Organization-Uppsala Monitoring Centre; D-ADRs, drug-induced adverse drug reactions (not including contrast media adverse drug reactions); * chi square test.</p

The characteristics of contrast media-induced adverse reactions: causality versus evaluation tool.

<p>WHO-UMC, World Health Organization-Uppsala Monitoring Centre; CM-ADRs, contrast media-induced adverse drug reactions;* chi square test.</p

The anatomical therapeutic chemical (ATC) classification of drugs involved in drug-induced adverse reactions (D-ADRs).

<p>^a ATC, anatomical therapeutic chemical; N, nervous system; J, systemic anti-infective agents; M, musculoskeletal system; R, respiratory system; A, digestive system; H, systemic hormonal preparations (excluding sex hormones and insulin).</p><p>The anatomical therapeutic chemical (ATC) classification of drugs involved in drug-induced adverse reactions (D-ADRs).</p