Analysis of Spontaneous Reports of Hypoglycemia and Hyperglycemia Associated with Marketed Systemic Fluoroquinolones Made to the Canadian Adverse Drug Reaction Monitoring Program
Bibliographic record
Abstract
Hypoglycemia, an adverse effect that may develop rapidly and progress to cause potentially serious consequences over a short period of time, is difficult to monitor in both outpatients and inpatients, and may be associated with serious central nervous system sequelae. Four recently published cases of severe acute hypoglycemia with gatifloxacin stimulated a review of the published literature and spontaneous adverse drug reaction reports made in Canada on fluoroquinolone-induced hypoglycemia or hyperglycemia. A search of the English literature for published reports of hypoglycemia associated with ciprofloxacin, gatifloxacin, levofloxacin, and moxifloxacin revealed 2 published case reports of hypoglycemia attributed to the potential drug–drug interaction of an oral hypoglycemic agent with ciprofloxacin; 4 such reports with gatifloxacin; and no reports with either levofloxacin or moxifloxacin. All spontaneously reported adverse drug reactions made to the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) listed under the Metabolic and Nutritional Disorders category for the 3 marketed respiratory fluoroquinolones (gatifloxacin, levofloxacin, and moxifloxacin) were then obtained. Altogether, 25 (93%) of 27 reports in this category were due to either hypoglycemia or hyperglycemia with gatifloxacin; 4 (11%) of 35 reports, with levofloxacin; and 1 (10%) of 10 reports, with moxifloxacin. The number of case reports for hypoglycemia (x2 = 24; p < 0.001), hyperglycemia (x2 = 8; p < 0.05), and total (hypoglycemia, hyperglycemia, and both hypoglycemia and hyperglycemia) (x2 = 46; p < 0.001) was significantly higher for gatifloxacin than for either levofloxacin or moxifloxacin. The CADRMP reports for hypoglycemia or hyperglycemia with the respiratory fluoroquinolones may have identified a safety signal for gatifloxacin. A systematic analysis to determine causality, risk factors, and incidence of hypoglycemia or hyperglycemia may be warranted.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.008 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.006 | 0.004 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".