Evgenia Gourgari1, Erin E Wilhelm2, Hamid Hassanzadeh2, Vanita R Aroda3, Ira Shoulson2. 1. Division of Pediatric Endocrinology, Department of Pediatrics, Georgetown University Medical Center, Washington, DC, United States; Program for Regulatory Science & Medicine, Georgetown University, Washington, DC, United States. Electronic address: eg685@georgetown.edu. 2. Program for Regulatory Science & Medicine, Georgetown University, Washington, DC, United States. 3. MedStar Health Research Institute, Hyattsville, MD, United States.
Abstract
AIMS: 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. METHODS: We searched four public references and reviewed all FDA-approved labels for "indication and usage," "adverse effects," "warnings and precautions," and "cardiovascular outcomes" from October 1982 to July 2016. We also reviewed FDA drug-safety communications from January 2015 to May 2017. RESULTS: 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. CONCLUSIONS: 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.
AIMS: 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. METHODS: We searched four public references and reviewed all FDA-approved labels for "indication and usage," "adverse effects," "warnings and precautions," and "cardiovascular outcomes" from October 1982 to July 2016. We also reviewed FDA drug-safety communications from January 2015 to May 2017. RESULTS: 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. CONCLUSIONS: 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.
Authors: Laura M Nally; Jennifer L Sherr; Michelle A Van Name; Anisha D Patel; William V Tamborlane Journal: Expert Rev Clin Pharmacol Date: 2019-05 Impact factor: 5.045
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