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Case reports of suspected adverse drug reactions—systematic literature survey of follow-up

Yoon Kong Loke , Deirdre Price , Sheena Derry , Jeffrey K Aronson
Table 1

Case reports of suspected adverse reactions that had been subjected to further evaluation: case reports that had been cited by validation studies (identified through the Web of Knowledge Citation Index)

DrugAdverse eventsTimes citedFollow-up validation studiesNature of validation studies (and date of first study)
Tacrolimusw1Aplastic anaemia, marrow aplasia11Records of 106 patients reviewed; 11 haematological abnormalities thought to be due to tacrolimus (2001)w64
Omeprazolew2Lethargy31Prescription event monitoring study showed that rate of malaise/lethargy was 0.07 per 1000 days' exposure (2000)w65
Trimethoprimw3Uveitis, aseptic meningitis71Laboratory study found increased IL6 production in response to trimethoprim in mononuclear cells of trimethoprim-sensitive women compared with controls (1999)w66
Omeprazolew4Optic neuropathy91CYP2C19 genotyping of patients with ocular adverse effects; only 2/279 were poor metabolisers, probably not related to ocular effects (2002)w67
Clarithromycin-disopyramide interactionw5QT interval prolongation, cardiac arrest, ventricular arrhythmias91Controlled laboratory study found that troleandomycin was potent inhibitor of disopyramide metabolism in liver microsomes (2000)w68
Indinavirw6Severe acute hepatitis771010 uncontrolled cohort studies showed varied rates of hepatotoxicity, but confounded by hepatitis B and C coinfection and the use of multiple antiviral drug combinations (1999)
Indinavirw7Lipomatosis7915Four controlled cohort studies showed metabolic changes and abnormal fat distribution; nine uncontrolled cohort studies; one data mining study; and one laboratory investigation of adipocytes exposed to indinavir (1998)
Vigabatrinw8Visual field constriction/defect1533410 controlled cohort studies showed that rate of visual constriction was much higher in patients who took vigabatrin; 20 uncontrolled cohort studies; one trial; one genetic study; one animal study; one prescription event monitoring study (1999)
Acarbosew9Hepatotoxicity232Data from clinical trials and surveillance study showed no rise in liver enzymes (1999)w69-70