FDA Allows Marketing of First A1C Test Labeled for Diagnosis of Diabetes by Health Care Professionals
5/23/13: FDA announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals. This is the first A1C test that FDA has allowed to be marketed for this use. The A1C tests currently on the market are FDA-cleared for monitoring a patient’s blood glucose control, but not for diagnosing diabetes.
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FDA Investigating Reports of Possible Increased Pancreatitis Risk and
Pre-Cancerous Findings of the Pancreas from Incretins
3/14/13: FDA is evaluating unpublished new findings that suggest increased pancreatitis risk and pre-cancerous cellular changes in patients with type 2 diabetes treated with incretins. Incretin drugs include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). FDA previously warned the public about postmarketing reports of acute pancreatitis, including fatal and serious nonfatal cases, associated with the use of the incretins, exenatide and sitagliptin.
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Important Safety Label Changes to Cholesterol-Lowering Statin Drugs
2/28/12: FDA has approved important safety label changes for statins, a class of cholesterol-lowering drugs. Labels have been revised to remove the need for routine periodic monitoring of liver enzymes; add information about the potential for cognitive side effects, and reports of increased blood sugar and A1C; add new contraindications to the lovastatin label, which has been extensively updated.
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