The Food and Drug Administration (FDA) has confirmed that Bristol-Myers Squibb Co. has announced significant labeling changes for its antibiotic Tequin, which is used in the treatment of pneumonia, bronchitis, uncomplicated gonorrhea, and various infections.
According to the FDA Press Release, a letter from the company to healthcare professionals gives the reason for the enhanced warnings as “a result of continued reports of serious cases of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) in patients receiving Tequin.â€ÂThe FDA noted that, since its approval in 1999, “there have been rare cases of life-threatening events reported globally in patients treated with the drug. Most of these events were reversible when properly managed, but a few had fatal outcomes.â€Â
In 2002, 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.â€Â
The new changes “strengthen the existing WARNING on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), 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.â€Â
The FDA announced that it “will continue monitoring Tequin’s safety to ensure that its benefits outweigh the risks to patients.â€Â
(Source: FDA Press Release and FDA Drug Database)
