Onglyza Heart Problems Topic of Upcoming FDA Advisory Committee

In response to concerns about the potential for heart problems from Onglyza side effects, the FDA will convene an advisory panel next month to review the risks associated with AstraZeneca’s diabetes drug, as well as Kombioglyza XR, which combines Onglyza with metformin. 

The FDA announced earlier this month that a meeting of its Endocrinologic and Metabolic Drugs Advisory Committee will be held on April 14, at which time the heart risks associated with the diabetes drugs will be reviewed by a group of independent experts.

Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol-Myers Squibb, but is now owned wholly by AstraZeneca. It was approved by the FDA in July 2009 for treatment of type 2 diabetes, and the medication is part of a class of drugs known as incretin mimetics, which also includes Januvia, Janumet, Byetta, Victoza and other widely used medications. However, only drugs with the active ingredient saxagliptin are being reviewed.

The FDA launched an investigation into the potential heart risks with Onglyza last year, following the publication of a study by the New England Journal of Medicine in 2013.

In that study, researchers found that the rate of hospitalization due to heart failure among Onglyza users was increased compared to those given a placebo. The study was funded by AstraZeneca and Bristol-Meyers Squibb, looking at data from more than 16,000 patients to determine whether Onglyza carried heart benefits.

The FDA requested clinical data that could reveal if there is a causal link between Onglyza and heart problems.

The advisory committee will discuss the results of the study and vote on any recommendations to the FDA regarding whether any regulatory actions are necessary to protect the public. While the advisory committee’s recommendations are non-binding, such findings often have a significant influence on the FDA’s ultimate decisions.

Onglyza Pancreatic Cancer Concerns

Onglyza is a DPP-4 inhibitor, which is part of a class of drugs known as incretin mimetics, which works by mimicking the incretin hormones the body usually produces to naturally stimulate the release of insulin in response to a meal. The diabetes drug brought in more than $700 million in sales in 2012.

In addition to the potential risk of heart failure, studies have suggested that users may face a risk of pancreatic cancer from Onglyza and other incretin mimetic diabetes drugs.

A number of Byetta lawsuits, Januvia Lawsuits, Janumet lawsuits and Victoza lawsuits have been filed in courts throughout the country, involving allegations that users of these other incretin mimetics developed pancreatic cancer.

The incretin mimetic litigation pending throughout the federal court system has been consolidated as part of an MDL, or Multidistrict Litigation, which is centralized before U.S. District Judge Anthony J. Battalglia in the Southern District of California to reduce duplicative discover, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.