Stronger Warning for Antibiotic Tequin

Feb. 24, 2006 - The FDA has added a warning against the use of the antibiotic Tequin in people with diabetes after reports of problems with high blood sugar and low blood sugar associated with the drug.

Tequin is an antibiotic used to treat various infections including pneumonia, bronchitis, some sexually transmitted diseases, and infections of the urinary tract, kidneys, and skin.

The FDA and the manufacturer of the drug, Bristol-Myers Squibb, have received reports of serious cases of high blood sugar (hyperglycemia) and low blood sugar ( hypoglycemia) in people receiving Tequin. Since Tequin was approved in 1999, there have also been rare cases of life-threatening side effects associated with the drug, but most of these were reversible when properly managed.

Information about the possible risk of low blood sugar and high blood sugar was added to Tequin's label in 2002.

Yesterday, Bristol-Myers Squibb Co. announced that it will change Tequin's labeling information to strengthen the warnings section about these possible side effects as well as add a warning against the use of the drug in people with diabetes.

The label will also include information on identifying other risk factors for developing low blood sugar and high blood sugar, such as decreased kidney function, use of glucose-altering medications, and advanced age while using Tequin.

The FDA says it will continue to monitor Tequin's safety to ensure that its benefits outweigh the risks to patients.