Table 2.
Clinical Features & Outcomes
| Pat. No. | Clinical features# including liver enzymes** | Probability¶ & causality index score§ | Outcome |
| 1 | Systemically unwell, fever, rash. No eosinophilia. RF & ANA -ve. Transaminases >7× & alk. phos. >2× ULN. Bilirubin <2× ULN. Hepatocellular pattern. Hepatitis B & C status unknown. | Highly probable 4 | Recovered |
| 2 | Nausea, dizziness, pruritis, rash, headache. No eosinophilia. RF -ve. ANA 1:400. Transaminases >2× & alk. phos. >8× ULN. Bilirubin <2× ULN. Mixed pattern. Hepatitis B & C status unknown. | Highly probable 2 | Recovered |
| 3 | Lymphadenopathy, rash, fever, headaches, interstitial nephritis. Eosinophilia. RF & ANA -ve. Transaminases >4× & alk. phos. >2× ULN. Bilirubin <2× ULN. Mixed pattern. Hepatitis B & C status unknown. | Highly probable 6 | Recovered. Given steroids. |
| 4 | Jaundice, systemically unwell. No eosinophilia. ANA-ve. RF not done. Transaminases >4× & alk. phos. >8× ULN. Bilirubin >10× ULN. Mixed pattern. Hepatitis B & C negative. | Possible 4 | Recovered |
| 5 | Hepatic failure, rash, fever, diarrhoea. Lymphocytosis. No eosinophilia. ANA 1:40. RF +ve. Transaminases >50× & alk. phos. >1.5× ULN. Bilirubin >10× ULN. Hepatocellular pattern. Hepatitis B, C, & CMV negative. | Highly probable 8 | Given steroids. Died after liver transplant |
| 6 | Hepatic failure preceded by nausea, vomiting, abdominal pain, diarrhoea. Eosinophilia. RF & ANA-ve. Transaminases >250× & alk. phos. >2× ULN. Bilirubin >6× ULN. Hepatocellular pattern. Hepatitis B, C & CMV negative. | Highly probable 9 | Recovered after liver transplant |
| 7 | Abdominal pain, anorexia, nausea, rash, hypotension. Monocytosis. No eosinophilia. RF & ANA -ve. Transaminases >4× & alk. phos. >2.5× ULN. Bilirubin <2× ULN. Mixed pattern. Hepatitis B, C, & CMV negative. | Probable 7 | Recovered |
| 8 | Nausea, vomiting, fever, rash, pruritus, sweating. Monocytosis & Eosinophilia. RF +ve. ANA 1:1600 post sulfasalazine. No pre-treatment value ANA. Transaminases >28× & alk. phos. >2.5× ULN. Bilirubin >2× ULN. Hepatocellular pattern. Hepatitis B, C & CMV negative. | Highly probable 7 | Given steroids. Recovered |
| 9 | Lethargy, rash, dry cough, fever. Monocytosis. No eosinophilia. RF & ANA -ve. Transaminases >10× & alk. phos. >2× ULN. Bilirubin <2× ULN. Mixed pattern. Hepatitis B, C & CMV negative. | Highly probable 4 | Recovered |
| 10 | Abdominal pain, nausea, vomiting, dizziness, palpitations, worsening joint pain. No eosinophilia. ANA 1:100. RF+ve. Transaminases >4× & alk. phos. >5× ULN. Bilirubin <2× ULN. Mixed pattern. Hepatitis B & C status unknown. | Possible 2 | Given steroids. Recovered |
# Eosinophilia refers to any value above normal. Some patients had a rise in eosinophil count above baseline but levels did not rise above the normal range. ** ULN = upper limit of normal. Pattern of toxicity classified as hepatocellular or mixed/cholestatic using published criteria [12].
¶Probability was determined by consensus and the clinical judgement of two senior clinicians according to a 5 point scale: highly probable, probable, possible, unlikely or excluded. & § Causality index scores were determined according to the methods described by Danan and Benichou (reference 12). A score of between -9 and +15 is possible on this scale: scores of <0 are considered to exclude drug toxicity; of 1–2 as 'unlikely'; 3–5 as 'possible'; 6–8 as 'probable' and over 8 'highly probable'. ANA: Anti-nuclear antibody. RF: rheumatoid factor. CMV: