Table 1: Reports submitted to Health Canada of suspected adverse reactions (ARs) of hypoglycemia and hyperglycemia associated with gatifloxacin (Tequin™) from Feb. 21, 2001, to Feb. 28, 2003*
|
Variable |
Hypoglycemia |
Hyperglycemia |
Hypoglycemia |
| Mean age (and range) of patients, yr | 74 (49–87) | 75 (52–102) | 70 (61–79) |
| Female:male ratio | 1:1 | 4:3 | 1:1 |
| Blood glucose values reported, mmol/L† | 1.4-3.8 | 15-58 | 3.0-14 |
| Onset of reaction after start of gatifloxacin therapy (no. of reports) | < 24 h (16) 24–72 h (2) > 72 h (1) |
< 4 d (3) 4–10 d (4) |
< 24 h (2) |
| Reaction terms reported‡ (no. of reactions) | Hypoglycemia (18), tremor (2), hypoglycemic coma (1), NPN (serum creatinine) increased (1), confusion (1), paresthesia (1), dyspnea (1), nausea (1), convulsions (1), ataxia (1) | Hyperglycemia (7), dehydration (2), plasma osmolality increased (2), NPN (serum creatinine) increased (2), renal function abnormal (2), diabetic coma (1), malaise (1), electrolyte abnormality (1), respiratory insufficiency (1), tachycardia (1), atelectasis (1), bundle branch block (1), cardiac failure (1), confusion (1), polydipsia (1), polyuria (1), nausea (1) | Hypoglycemia (2), hyperglycemia (2) |
| Outcome reported (no. of reports) | Recovered: 17 Unknown: 2 |
Recovered: 5 Death: 2 |
Recovered : 1 Not yet recovered: 1 |
| History of diabetes (no. of reports) | Type 2: 18 Unknown: 1 |
Type 2: 5 None: 2 |
Type 2: 2 |
| Concomitant use of
hypoglycemic agent, no. of reports§ |
18 | 2 | 2 |
| Creatinine clearance < 0.67 mL/s (40 mL/min), no. of reports¶ | 8 | 3 | --- |
| *These data
cannot be used to determine the incidence of ARs because ARs remain
underreported and total patient exposure is unknown.
†Normal range for fasting or before-meal glucose level is 3.8–6.1 mmol/L in nondiabetic patients; target range in diabetic patients is 4–7 mmol/L.6 ‡Several reaction terms may be listed per AR report. Reaction terms are based on the "preferred term" of the World Health Organization (WHO) Adverse Reaction Dictionary (WHOART). §Hypoglycemic agents: glyburide, glicazide, tolbutamide or insulin. ¶Renal function was reported in 13 of the 28 cases: decreased renal function (11), renal function in normal range (2) and unknown (15). |
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