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)
| Drug | Adverse events | Times cited | Follow-up validation studies | Nature of validation studies (and date of first study) |
|---|---|---|---|---|
| Tacrolimusw1 | Aplastic anaemia, marrow aplasia | 1 | 1 | Records of 106 patients reviewed; 11 haematological abnormalities thought to be due to tacrolimus (2001)w64 |
| Omeprazolew2 | Lethargy | 3 | 1 | Prescription event monitoring study showed that rate of malaise/lethargy was 0.07 per 1000 days' exposure (2000)w65 |
| Trimethoprimw3 | Uveitis, aseptic meningitis | 7 | 1 | Laboratory study found increased IL6 production in response to trimethoprim in mononuclear cells of trimethoprim-sensitive women compared with controls (1999)w66 |
| Omeprazolew4 | Optic neuropathy | 9 | 1 | CYP2C19 genotyping of patients with ocular adverse effects; only 2/279 were poor metabolisers, probably not related to ocular effects (2002)w67 |
| Clarithromycin-disopyramide interactionw5 | QT interval prolongation, cardiac arrest, ventricular arrhythmias | 9 | 1 | Controlled laboratory study found that troleandomycin was potent inhibitor of disopyramide metabolism in liver microsomes (2000)w68 |
| Indinavirw6 | Severe acute hepatitis | 77 | 10 | 10 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) |
| Indinavirw7 | Lipomatosis | 79 | 15 | Four 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) |
| Vigabatrinw8 | Visual field constriction/defect | 153 | 34 | 10 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) |
| Acarbosew9 | Hepatotoxicity | 23 | 2 | Data from clinical trials and surveillance study showed no rise in liver enzymes (1999)w69-70 |