Health Canada received 28 reports of abnormal glucose metabolism associated with Gatifloxacin (44% of total reports received for the drug) from February 21, 2001 (date marketed in Canada), to February 28, 2003: 19 were for hypoglycemia, 7 were reported hyperglycemia, and 2 involved both hypoglycemia and hyperglycemia.
Twenty-five of the cases involved patients with type 2 diabetes, 2 involved nondiabetic patients, and in 1 case the patient's diabetic status was unknown.
Of the 28 cases, 19 of the patients were admitted to hospital or had a prolonged hospital stay because of the reaction. The 2 patients who died had hyperglycemia, and had no prior history of diabetes or decreased renal function at the time of the reaction.
The Canadian product monograph for Tequin was updated in December 2002, in response to the reported cases of serious, life-threatening disturbances of glucose homeostasis.
In December 2005, Health Canada, citing evidence indicating of glucose disorders, asked BMS to submit revised product information for Tequin. BMS submitted information for review, but Health Canada noted that given the availability of other antibiotics, patients with diabetes should be prescribed alternative antibiotics while the agency was reviewing the data.
Also in December 2005, according to Health Canada, BMS issued a letter to Canadian health care providers and a public health advisory about a possible link between the antibiotic and blood glucose disorders, after serious cases of both low blood sugar and high blood sugar were reported in patients worldwide.
In February 2006, the FDA finally entered the fray and joined Health Canada in announcing that BMS had informed doctors that Tequin should not be used with diabetics, and that elderly patients, as well as those with kidney problems, were more likely to experience serious side effects.
Also in February, BMS revised Tequin's label in the US to warn of the potential fatal risks of high and low blood-sugar levels and recommended against the use of the drug by diabetics.
The changes were said to be made in response to the results of 2 studies conducted by a team of Canadian scientists from the Institute of Clinical Evaluative Sciences, published in the New England Journal of Medicine.
The first study involved 788 patients over the age of 66, who received treatments for hypoglycemia within 30 days after antibiotic therapy, and the second involved 470 patients in the same age group who were treated for hyperglycemia within 30 days after antibiotic therapy.
When compared to other antibiotics, the use of Tequin was found to be linked to a 4.3 times greater risk of hypoglycemia, and a 16.7 times higher risk of hyperglycemia. The increased risks were present in both diabetic and non-diabetic patients.
BMS and the FDA feigned shock over these finding but in reality, the numbers were not that much higher than those reported above by Health Canada in 2002.
Experts say Tequin patients should be alerted to the signs of blood sugar problems which can include:
Confusion
Visual disturbances
Heart palpitations
Tremors
Frequent urination
Increased thirst
Dry mouth
Back in December 2001, other serious long-term side effects associated with fluoroquinolones were reported by, Dr Jay Cohen, MD, President and Executive Director of the Center for the Prevention of Medication Side Effects, in a study published in the Annals of Pharmachotherapy.
In his study, Dr Cohen found that severe reactions were occurring in young, healthy, and active patients, who often were receiving antibiotic therapy for mild infections such as sinusitis, urinary tract or prostate infections.
Twenty-five of the cases involved patients with type 2 diabetes, 2 involved nondiabetic patients, and in 1 case the patient's diabetic status was unknown.
Of the 28 cases, 19 of the patients were admitted to hospital or had a prolonged hospital stay because of the reaction. The 2 patients who died had hyperglycemia, and had no prior history of diabetes or decreased renal function at the time of the reaction.
The Canadian product monograph for Tequin was updated in December 2002, in response to the reported cases of serious, life-threatening disturbances of glucose homeostasis.
Also in December 2005, according to Health Canada, BMS issued a letter to Canadian health care providers and a public health advisory about a possible link between the antibiotic and blood glucose disorders, after serious cases of both low blood sugar and high blood sugar were reported in patients worldwide.
In February 2006, the FDA finally entered the fray and joined Health Canada in announcing that BMS had informed doctors that Tequin should not be used with diabetics, and that elderly patients, as well as those with kidney problems, were more likely to experience serious side effects.
Also in February, BMS revised Tequin's label in the US to warn of the potential fatal risks of high and low blood-sugar levels and recommended against the use of the drug by diabetics.
The changes were said to be made in response to the results of 2 studies conducted by a team of Canadian scientists from the Institute of Clinical Evaluative Sciences, published in the New England Journal of Medicine.
The first study involved 788 patients over the age of 66, who received treatments for hypoglycemia within 30 days after antibiotic therapy, and the second involved 470 patients in the same age group who were treated for hyperglycemia within 30 days after antibiotic therapy.
When compared to other antibiotics, the use of Tequin was found to be linked to a 4.3 times greater risk of hypoglycemia, and a 16.7 times higher risk of hyperglycemia. The increased risks were present in both diabetic and non-diabetic patients.
BMS and the FDA feigned shock over these finding but in reality, the numbers were not that much higher than those reported above by Health Canada in 2002.
Experts say Tequin patients should be alerted to the signs of blood sugar problems which can include:
Confusion
Visual disturbances
Heart palpitations
Tremors
Frequent urination
Increased thirst
Dry mouth
Back in December 2001, other serious long-term side effects associated with fluoroquinolones were reported by, Dr Jay Cohen, MD, President and Executive Director of the Center for the Prevention of Medication Side Effects, in a study published in the Annals of Pharmachotherapy.
In his study, Dr Cohen found that severe reactions were occurring in young, healthy, and active patients, who often were receiving antibiotic therapy for mild infections such as sinusitis, urinary tract or prostate infections.
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