20-Apr-15 5:00 PM  CST

FDA Releases New Warning Against Astra-Zeneca Diabetic Drug

Friday the federal Food and Drug Administration release a new warning against Astra-Zeneca’s diabetic drug Onglyza (saxagliptin). Onglyza belongs to a class of diabetic drugs known as Dipeptyl Peptide 4-Inhibitors (DPP-4 Inhibitors) or gliptins. DPP-4 inhibitors work by blocking the enzyme DPP-4. DPP-4 enzymes extinguish the hormone incretin; a hormone found specifically in the small intestine, helps the body to produce insulin when needed. Because DPP-4 Inhibitors work by helping to increase the hormone incretin, they are uniquely different from any other class of type-2 diabetic drug on the U.S. market. Januvia (sitagliptin) was the first DPP-4 Inhibitor approved by the FDA.

As encouraging as DPP-4 Inhibitors have been they have been plagued by problems from the moment that hit the U.S. market. This latest warning from the FDA on Friday only adds to the mounting concerns about DPP-4 Inhibitors. According to the FDA patients taking Onglyza experienced “significant or near significant” risk for death related to all causes, not just heart related death. Since 2008 the FDA has required manufacturers of type 2 diabetic drugs to supply information that proves their drugs do not increase the risk of heart disease or heart failure.

Onglyza clinical trials first published in 2013 found that patients who took Onglyza were at a 27% increased risk for hospitalization due to heart failure compared to patients who did not take Onglyza. First approved in 2009, Onglyza had more than 820 million dollars in sales in 2014.

The FDA stated on Friday that they would continue its clinical analysis on Onglyza before making any final decisions concerning the drug’s fate. Furthermore, the FDA encouraged those taking Onglyza for type 2 diabetes to continue with their drug therapy. Patients taking Onglyza with concerns about the safety of the drug should initiate a conversation with their physician.




Edney, A., (2015),”AstraZeneca’s Diabetic Drug May Raise Death Risk, FDA Says,” Bloomberg News, http://www.bloomberg.com/news/articles/2015-04-10/astrazeneca-type-2-diabetes-drug-may-raise-death-risk-fda-says, retrieved, 11. April 2015


Food and Drug Administration, (2015), “FDA Safety Communication”, FDA.com, http://www.fda.gov/Drugs/DrugSafety/ucm385287.htm, retrieved, 11. April 2015

For additional information on this article, please contact:
Kelley Simmons
Source: Sandy Andrews, CPhT, BLS  

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