International Journal of Case Reports: Diabetes.


International Journal of Case Reports: Diabetes.


FDA-approved drug labels are an important source of information for clinicians who prescribe medications for treatment of diabetes. We reviewed drug labels to (1) understand the landscape of classes of medications approved for type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM), (2) explore the indications and safety information and (3) examine their cardiovascular safety.


We searched the FDA public database of approved diabetic medications8 and three other public references with information on FDA approved medications: WebMD,9 CenterWatch10 and Medscape11 to retrieve the label information for all diabetes medications from October 1982 to July 2016. Specifically, for the FDA public database we searched the medications listed under sections “Insulins and Diabetes Drugs Approved Between 2013–2016”, “Insulins and Diabetes Drugs Approved Between 2000–2012” and “Insulins and Diabetes Drugs Approved Before 1999”, which have information about drugs approved since October 1982.8 We understand that information about diabetes drugs might be available on different places within the FDA website but we chose this method because in our opinion this was the most comprehensive list of diabetes drugs available at the FDA website. In addition, to capture information that has been released by the FDA but has not yet been included on the actual FDA label, we reviewed the FDA website for recent “drug safety communications”12 and “press announcements”13 published between January 1, 2015, and May 30th, 2017, for information relevant to diabetes drugs safety and cardiovascular disease..


The labels reveal 12 classes of medications approved for T2DM with only 2 classes approved for T1DM. There is emerging evidence about cardiovascular safety and risk reduction from diabetes medications which is now being incorporated in drug labels.


All currently available diabetes medications are approved for adults with T2DM with a remarkably limited number for adults with T1DM and children with T1DM or T2DM. The incorporation of emerging data on cardiovascular outcomes in FDA drug labels is expected to influence the way physicians treat patients with diabetes.

Best Regards
Sarah Jhonson
Managing Editor
International Journal of Case Reports