The U.S. Food and Drug Administration (FDA) says the labeling changes update the prescription information as a result of continued reports of serious cases of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) in patients receiving Tequin.
Since the approval of Tequin in 1999, there have been rare cases of life-threatening events in patients treated with the drug. Most of these events were reversible when properly managed, but a few had fatal outcomes.
Information about the risks of low blood sugar and high blood sugar was added to the WARNINGS section of the U.S. labeling in 2002.
Thursday's changes strengthen the existing WARNING on hypoglycemia and hyperglycemia. They also add a CONTRAINDICATION for use in diabetic patients, and include information identifying other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose altering medications while taking Tequin.
