Audience: Healthcare professionals and patients[Posted 02/16/2006] BMS notified FDA and healthcare professionals about proposed changes to the prescribing information for Tequin, including an updating of the existing WARNING on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), and a CONTRAINDICATION for use in diabetic patients. The changes also 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. The proposed changes are highlighted in the following "Dear Healthcare Provider" letter issued by BMS. Specific wording of these additions and revisions to the labeling is pending FDA review and approval.
[February 15, 2006 – Letter – BMS]