Tequin Diabetes Dangers.
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Tequin Diabetes & Hyperglycemia Lawsuit Information: Dear Doctor" Letter from BMS About Tequin Dangers:
"Dear Doctor" Letter from BMS About Tequin Dangers:
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Dear Healthcare Provider:
Bristol-Myers Squibb Company has notified the Food and Drug Administration and would like to inform you of important safety information regarding TEQUIN (gatifloxacin) Tablets and Injection. The TEQUIN Prescribing Information has been revised to include a CONTRAINDICATION in diabetic patients due to serious reports of hypoglycemia and hyperglycemia (dysglycemia). Additionally, the WARNINGS and PRECAUTIONS sections have been updated to identify other risk factors for dysglycemia (older age, renal insufficiency, concomitant glucose-altering medications) while taking TEQUIN, and include a recommendation for close medical monitoring.
In postmarketing experience worldwide, serious cases of both hypoglycemia and hyperglycemia have been reported in patients receiving TEQUIN. Although most of these cases were reversible, very rare events of dysglycemia were life-threatening, and a few resulted in fatal outcomes. In light of this data, Bristol-Myers Squibb Company has revised the product labeling for TEQUIN.
The following language has been added:
• CONTRAINDICATIONS
TEQUIN is contraindicated in patients with diabetes mellitus.
The following sections have been revised:
• WARNINGS: Disturbances in Blood Glucose
DISTURBANCES OF BLOOD GLUCOSE, INCLUDING SYMPTOMATIC HYPOGLYCEMIA AND HYPERGLYCEMIA, HAVE BEEN REPORTED WITH TEQUIN, USUALLY IN DIABETIC PATIENTS. HOWEVER, HYPOGLYCEMIA AND PARTICULARLY HYPERGLYCEMIA HAVE OCCURRED IN PATIENTS WITHOUT A HISTORY OF DIABETES. IN ADDITION TO DIABETES, OTHER RISK FACTORS ASSOCIATED WITH DYSGLYCEMIA WHILE TAKING TEQUIN INCLUDE OLDER AGE, RENAL INSUFFICIENCY AND CONCOMITANT GLUCOSE-ALTERING MEDICATIONS (PARTICULARLY HYPOGLYCEMIC MEDICATIONS). PATIENTS WITH THESE RISK FACTORS SHOULD BE CLOSELY MONITORED FOR GLUCOSE DISTURBANCES. IF SIGNS AND SYMPTOMS OF EITHER HYPOGLYCEMIA OR HYPERGLYCEMIA OCCUR IN ANY PATIENT BEING TREATED WITH TEQUIN, APPROPRIATE THERAPY MUST BE INITIATED IMMEDIATELY AND TEQUIN SHOULD BE DISCONTINUED.
Transient disturbances in glucose homeostasis including an increase in serum insulin and decrease in serum glucose usually within 3 days of initiating therapy, sometimes associated with severe hypoglycemia, have been reported. Hyperglycemia, in some cases severe, also have been observed, usually after the third day of TEQUIN administration.
During the postmarketing period, there have been very rare reports of serious disturbances of glucose homeostasis in patients treated with TEQUIN. These include hyperosmolar non-ketotic hyperglycemic coma, diabetic ketoacidosis, hypoglycemic coma, convulsions and mental status changes (including loss of consciousness). Most of these events were reversible when appropriately managed, although a few resulted in fatal outcome. (See CLINICAL PHARMACOLOGY: Glucose Homeostasis, CONTRAINDICATIONS, WARNINGS: Disturbances in Blood Glucose and ANIMAL PHARMACOLOGY.)
### END OF BMS DOCUMENT ###
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Important Notice: [^]
Persons seeking to preserve any potential legal claims should contact an attorney promptly, since all states have mandatory time periods in which lawsuits must be filed with the courts; otherwise, they may be forever barred.
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