Antibiotic Can Cause Severe Blood Sugar Changes
December 19, 2005
Dear Health Care Professional, Bristol-Myers Squibb (BMS) Canada, following discussions with Health Canada,would like to inform you of the following important safety information regardingthe use of TEQUIN* (gatifloxacin).
Bristol-Myers Squibb is committed to the safe use of its medications. As themanufacturer and distributor of TEQUIN* (gatifloxacin), we wish to remind allconcerned physicians of the following Warning which appears in the currentProduct Monograph: "Changes in Blood Glucose" Disturbances of blood glucose, including symptomatic hyper- and hypoglycemia,have been reported with TEQUIN, usually but not always in diabetic patients.Therefore, careful monitoring of blood glucose is recommended when TEQUIN isadministered to diabetic patients. Studies conducted in patients with type II diabetes mellitus controlled onoral hypoglycemic agents have demonstrated that TEQUIN is associated withtransient disturbances in glucose homeostasis, including an increase in seruminsulin and decrease in serum glucose following administration of initial doses(i.e. first two days of treatment), sometimes associated with symptomatichypoglycemia. Increases in fasting serum glucose were also observed, usuallyafter the third day of TEQUIN administration and continuing throughout theduration of treatment, but returning to pre-dose values by 14 days after thecompletion of treatment. In a postmarketing study involving over 15 000 patients, the occurrence ofhyperglycemic events related to TEQUIN was 0.007% in nondiabetic patients and1.3% in diabetic patients. The incidence of hypoglycemic events was 0.03% innondiabetic patients and 0.64% in diabetic patients. The incidence of serioushyperglycemia and hypoglycemia was 0.03% of the total population, all reversiblewith appropriate management, which included discontinuation of TEQUIN therapy. During the postmarketing period, there have been reports of seriousdisturbances of glucose homeostasis in patients treated with TEQUIN.Hypoglycemic episodes, in some cases severe, have been reported in patients withdiabetes mellitus treated with either sulfonylurea or non-sulfonylurea oralhypoglycemic medications. These events frequently occurred on the first day oftherapy and usually within 3 days following the initiation of TEQUIN.Hyperglycemic episodes, in some cases severe and associated with hyperosmolarnon-ketotic hyperglycemic coma, were reported in diabetic patients, mostlybetween 4 and 10 days following the initiation of TEQUIN therapy. Some of thehyperglycemic and hypoglycemic events were life-threatening. These reports wereextremely rare, and many of these patients had other underlying medical problemsand were receiving concomitant medications that may have contributed to theglucose abnormality. These events were reversible when appropriately managed. Episodes of hyperglycemia, including extremely rare hyperosmolar non-ketotichyperglycemic coma, occurred in patients not previously diagnosed with diabetesmellitus. Very elderly patients (>75 years of age) who may have unrecognizeddiabetes, age-related decrease in renal function, underlying medical problems,and/or are taking concomitant medications associated with hyperglycemia may beat particular risk for serious hyperglycemia. The dose of TEQUIN should be adjusted based on underlying renal function (seeDOSAGE AND ADMINISTRATION). When TEQUIN is used in diabetic patients, blood glucose should be closelymonitored. Signs and symptoms of hypoglycemia should be monitored, especiallyduring the first 3 days of therapy, and signs and symptoms of hyperglycemiashould be monitored in diabetics and patients who may be at risk forhyperglycemia, especially following the third day of therapy. If signs andsymptoms of either hypoglycemia or hyperglycemia occur in any patient beingtreated with TEQUIN, appropriate therapy must be initiated immediately andTEQUIN should be discontinued." Reporting rates determined on the basis of spontaneously reportedpost-marketing adverse reactions are generally presumed to underestimate therisks associated with health product treatments. The identification, characterization and management of marketed healthproduct-related adverse reactions are dependent on the active participation ofhealth care professionals in adverse reaction reporting programmes. Anyoccurrences of hypoglycaemia or hyperglycemia or other serious or unexpectedadverse reactions in patients receiving TEQUIN should be reported toBristol-Myers Squibb or Health Canada at the following addresses:
Your professional commitment in this regard has an important role inprotecting the well-being of your patients by contributing to early signaldetection and informed use of drugs. For a copy of the full Product Monograph on TEQUIN, please consult theBristol Myers Squibb Canada website at If you require any further information on TEQUIN* (gatifloxacin) or for thefull Product Monograph on TEQUIN*, please contact Bristol-Myers Squibb CanadaMedical Information at 866-463-6267. Sincerely, original signed by Dan Chiche, MD *TM of Bristol-Myers Squibb Company used under licence byBristol-Myers Squibb Canada Leaving "Antibiotic and Diabetes" to go "Home: Lower blood sugars"
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