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Table 2 Clinical Features & Outcomes

From: Hepatotoxicity associated with sulfasalazine in inflammatory arthritis: A case series from a local surveillance of serious adverse events

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

  1. # 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].
  2. ¶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:
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BMC Musculoskeletal Disorders

ISSN: 1471-2474

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