Table 1 –
Criterion | Rule | Interpretation | Point value |
---|---|---|---|
1. Delay from initial drug component intake to onset of reaction (Index Day) [−3 to 3] | 5–28 Days or If previous rxn to same drug: 1–4 days | Suggestive | +3 |
29–56 Days | Compatible | +2 | |
1–4 Days or If previous rxn to same drug: 5–56 Days | Likely | +1 | |
>56 Days | Unlikely | −1 | |
Started on or after the index day | Excluded | −3 | |
2. Drug present in the body on index day [−3 to 0] | Drug continued up to index day or stopped at a time point less than 5× the elimination half-life before the index day | Definite | 0 |
Drug stopped at a time point prior to the index day by more than five times the elimination half-life but liver to kidney function alterations or suspected drug interactions are present | Doubtful | −1 | |
Drug stopped at a time point prior to the index day by more than five times the elimination half-life without liver or kidney function alterations or suspected drug interactions. | Excluded | −3 | |
3. Prechallenge/rechallenge [−2 to 4] | SJS/TEN after use of the same drug | Positive specific for disease and drug | +4 |
SJS/TEN after use of similar drug or other reaction with same drug | Positive specific for disease or drug | +2 | |
Other reaction after use of similar drug | Positive unspecific | +1 | |
No known previous exposure to this drug | Not done/unknown | 0 | |
Exposure to this drug without any reaction (before or after reaction) | Negative | −2 | |
4. Dechallenge [−2 or 0] | Drug stopped (or unknown) | Neutral | 0 |
Drug continued without harm | Negative | −2 | |
5. Type of drug (notoriety) [−1 to 3] | Drug of the high-risk list according to previous case-control studies | Strongly associated | +3 |
Drug with definite but lower risk according to previous case-control studies | Associated | +2 | |
Several previous reports, ambiguous epidemiology results (drug “under surveillance”) | Suspected | +1 | |
All other drugs including newly released ones | Unknown | 0 | |
No evidence of association from previous epidemiology study with sufficient number of exposed controls | Not Suspected | −1 | |
Intermediate score: total of all previous criteria [−11 to 10] | |||
6. Other cause | Rank all drugs from highest to lowest intermediate score–if at least one has an intermediate score >3, subtract 1 point from the score of each of the other drugs taken by the patient (another cause more likely). | Possible | −1 |
Final score: [−12 to 10] |
Table adapted from: Sassolas, B., et al. ALDEN, an algorithm for assessment of drug causality in Stevens-Johnson Syndrome and toxic epidermal necrolysis: comparison with case-control analysis. Clin Pharmacol Ther 88, 60–68 (2010).