HSA would like to draw the attention of healthcare professionals to the known adverse effects of hypoglycaemia and hyperglycaemia associated with gatifloxacin (Tequin®, Bristol-Myers Squibb), a fluoroquinolone antibiotic, and the recent contraindication on the use of the drug in patients with diabetes mellitus.
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Post-marketing data
Serious cases of both hypoglycaemia and hyperglycaemia have been reported with gatifloxacin during post-marketing surveillance.
From the overseas spontaneous post-marketing reports, it was noted that cases of blood glucose disturbances usually occurred in diabetic patients. There were very rare events of hypoglycaemia and hyperglycaemia which were life-threatening. In the majority of cases, the patients had other underlying medical problems and were receiving concomitant medications that may have contributed to the glucose abnormality. A few of these cases resulted in fatalities.
The patients particularly at risk include diabetics and the elderly (>75 years of age) who may have unrecognised diabetes, age-related decrease in renal function, underlying medical problems, and/or are taking concomitant medications associated with dysglycaemia. However, dysglycaemia has been reported to occur in patients without a history of diabetes.
In a phase IV surveillance trial, “Tequin Clinical Experience Study” (TeqCES) which included over 15,000 patients, it was found that 0.007% of nondiabetic patients and 1.3% of diabetic patients experienced hyperglycaemia events, while 0.03% of nondiabetic patients and 0.64% of diabetic patients had hypoglycaemic events.1 In total, serious cases of glucose disturbances were reported in 0.03% of the total study population. These events were reversible with management, which included discontinuation of the drug.
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Effect on controlled type II diabetes mellitus
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Local situation
Locally, HSA has received an adverse drug reaction (ADR) report of an 84-year-old male patient who experienced hypoglycaemia after two days of therapy with gatifloxacin. The patient was on other concomitant medications such as nifedipine, candesartan and clopidogrel. He subsequently recovered from the ADR.
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Recommendations
patients with diabetes mellitus. The local package insert of Tequin® will be updated to reflect this new safety information.
Physicians are advised to closely monitor the blood glucose of nondiabetic patients who are at risk of dysglycaemic events for signs and symptoms of blood glucose disturbances. Risk factors include older age, renal insufficiency, drug interactions with glucose-altering medications (such as anti-diabetic agents like glibenclamide). If signs and symptoms of either hypoglycaemia or hyperglycaemia occur in any patient treated with gatifloxacin, appropriate therapy should be initiated immediately and gatifloxacin should be discontinued.
Physicians are reminded to report any suspected ADRs to gatifloxacin to the Pharmacovigilance Unit of the HSA.
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Reference
- BMS letter to doctors in Canada: “Important Safety Information on Tequin® (gatifloxacin)”, 19 Dec 2005.
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