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FDA Advisory Panel Recommends Increased Safety Warnings on Onglyza

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An FDA advisory panel has recommended that Onglyza (saxagliptin), a type 2 diabetes medication, should have its warning label updated to indicate that it could increase risk of heart failure.

Onglyza belongs to a class of drugs known as “dipeptidyl peptidase-4 (DDP-4) inhibitors.” Also called “incretin mimetics,” these drugs help control blood sugar levels by stimulating the pancreas to produce more insulin. Recent studies, however, have indicated that patients taking Onglyza may be more vulnerable to heart failure.

FDA Advisory Panel Recommends Increased Warnings for Onglyza

The FDA called a meeting of panelists from the Endocrinologic and Metabolic Drugs Advisory Committee to examine the research on Onglyza so far, and determine the safety risks. The panelists looked at results from the so-called “SAVOR” study, which was first published in 2013. The study, which involved over 16,000 participants, found a 27 percent increased risk of hospitalization for heart failure in those taking Onglyza over those taking a placebo.

After this study was published, the FDA conducted an additional analysis of the data in what has been called the “EXAMINE” study, and found that the heart failure concern was valid, and that there also seemed to be an increased risk of mortality, though the causes were so varied researchers couldn’t draw any conclusions from the data as to risk of death.

Considering all the information available so far, the panel recommended that the FDA require manufacturers Bristol-Myers Squibb and AstraZeneca to update the warnings on Onglyza to alert physicians and patients to the risk.

Onglyza Also Connected with Potential Increased Risk for Pancreatic Cancer

The FDA approved Onglyza in 2009 for the treatment of type 2 diabetes. Like other DDP-4 inhibitors, the drug has since been linked to a possible increased risk of pancreatic cancer, as well. Because of the way the drug works on the pancreas, it can cause inflammation of the organ, as well as possible enlargement and pre-cancerous changes.

A 2013 study, for instance, reported that patients who were treated with these drugs had an increased risk of problems with the pancreas, including enlargement and changes in the cells that could lead to cancerous tumors. A later 2014 study found conflicting results, but the FDA has stated that it continues to evaluate research on a potential connection.

AstraZeneca Positions Panel Recommendations in a Positive Light

On their website page, AstraZeneca positioned the FDA panel’s findings in a positive light, stating that members voted 13 to 1 that the results of the SAVOR study “demonstrated the use of saxagliptin in patients with type 2 diabetes has an acceptable cardiovascular risk profile.” They did acknowledge that the panel also suggested increased warnings on the label, and that out of 15 panel members, one voted to completely recall the drug from the market.

The company added that it will “conduct further investigation” into the SAVOR results to try to better understand the risk of heart failure.