Stakeholder Call: Drug Safety Communication on Labeling Changes for Diabetes Drugs Stakeholder

Dear Colleagues, 

You can participate in a stakeholder teleconference to discuss a recent FDA safety review that led to additional warnings on the labels of a specific class of type 2 diabetes medicines.

What: A briefing to discuss a FDA safety review which has resulted in adding to the warning labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization.

Date:December 17, 2015

Time: 1:30 PM ET

Who:

• Jean Marc-Guettier, MD, Director, Division of Metabolism and Endocrinology Products, Office of New Drugs, Center for Drug Evaluation and Research
• Jennifer Pippins, MD, MPH, Deputy Directory for Safety, Division of Metabolism and Endocrinology Products, Office of New Drugs, Center for Drug Evaluation and Research
• Helene Clayton-Jeter, OD, Director, Cardiovascular and Endocrine Liaison Program, Office of the Commissioner, Office of External Affairs, Office of Health and Constituent Affairs

Call in: Provide your number when you join the meeting to receive a call back. Alternatively call one of the following numbers:

• Local: 1-301-796-7777
• Toll free: 1-855-828-1770
• Passcode: SGLT2

View the Drug Safety Communication Announcement