Antibiotic Tequin: FDA and Health Canada Issue Warnings About Abnormal Blood-Sugar (Glucose) Levels That Can Be Fatal

Diabetic Patients Advised Not To Use Tequin Due To Concerns About Blood-Sugar Disorders (Dysglycemia)

In separate public advisories issued by the FDA and Health Canada in February 2006, doctors and patients were warned about the threat of rare but potentially fatal side effects associated with use of the antibiotic Tequin. According these advisories, Bristol-Myers Squibb Co. was putting stronger warnings on the Tequin label, or package insert, concerning cases of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) in patients using this widely-prescribed antibiotic.

Tequin (gatifloxacin) is an antibiotic manufactured by Bristol-Myers Squibb that was approved by the FDA in 1999 for the treatment of pneumonia, bronchitis, and other infections.

The Health Canada advisory regarding Tequin instructs that diabetic patients, should not use Tequin due to concerns about serious blood-sugar disorders, hyopglycemia and hyperglycemia, which are collectively known as dysglycemia.

According to the FDA MedWatch alert, "[s]ince the approval of Tequin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with [Tequin]." These reports of adverse events led to the initial warnings about the risks of low blood-sugar levels and high blood-sugar levels being added to the Tequin label by Bristol-Myers Squibb in 2002.

Dear Doctor Letter Warning

In a February 15, 2006 Dear Doctor letter regarding Tequin, Bristol-Myers Squibb said it had added new, stronger warnings to the Tequin label in order to provide additional information concerning the types of patients that are more likely to have the blood-sugar problems that have been linked to Tequin. In particular, this latest Tequin label change identifies some of the risk factors for developing hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), including:

• advanced age;
• renal insufficiency; and,
• concomitant glucose-altering medications while taking Tequin.

Meanwhile, a March 2006 editorial in The New England Journal of Medicine says that, at least, the Tequin label needs a black-box warning, and goes so far as to suggest the FDA should recall Tequin due to the fact that its unique risk of serious side effects outweighs any therapeutic benefits.

Read more on our Tequin Information Page >>