Alert, information sheets issued for Tequin
Following the "Dear Healthcare Professional" letter that Bristol-Myers Squibb distributed in February providing updated labeling for gatifloxacin (Tequin), the FDA has now issued an alert along with information sheets for patients and healthcare professionals as serious reports of hypo- and hyperglycemia continue to occur in both patients with and without diabetes. The new sheets remind patients that the drug should not be used by diabetics and lists other risk factors for developing changes in blood sugar levels: older age, abnormal kidney function, and taking other medications that affect blood sugar concomitantly with gatifloxacin.
Alert, information sheets issued for Tequin
Following the "Dear Healthcare Professional" letter that Bristol-Myers Squibb distributed in February providing updated labeling for gatifloxacin (Tequin), the FDA has now issued an alert along with information sheets for patients and healthcare professionals as serious reports of hypo- and hyperglycemia continue to occur in both patients with and without diabetes. The new sheets remind patients that the drug should not be used by diabetics and lists other risk factors for developing changes in blood sugar levels: older age, abnormal kidney function, and taking other medications that affect blood sugar concomitantly with gatifloxacin.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
