A recent preliminary review of FDA data indicates that the Onglyza risk of death may be uncommonly high.

The U.S. Food and Drug Administration (FDA) posted a report online as part of the lead up to a future advisory panel discussing both the Onglyza risk of death and the risks of a similar drug, Nesina, manufactured by Takeda Pharmaceutical Co.

This review takes into account a number of previous studies, including the well-known SAVOR trial. SAVOR—a trial of over 16,000 Onglyza patients—showed an increased risk of hospitalization from heart failure for patients taking Onglyza.

According to the FDA’s review of data, this increased risk of heart failure was found to be valid. The review also found that Onglyza risk of death from all causes may be another serious problem. Indeed, the FDA review found that patients face “a significantly increased risk of all-cause mortality.”

It is important to note that the causes for this increased Onglyza risk of death are multifaceted. Patients who faced the greatest risk of death were often those with many complications, including serious medical conditions, prior to death.

The FDA review notes that it is “not reassured” by this Onglyza risk of death increase, “and we do not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance.”

Though Takeda’s Nesina drug underwent a similar review, a similar increased risk was not found.

Onglyza Background

Onglyza (a combination of saxagliptin and metformin) is a popular diabetes drug jointly manufactured by Bristol-Myers Squibb and AstraZeneca Pharmaceuticals. Onglyza belong to a relatively new class of diabetes drugs known as incretin mimetics, used to control type 2 diabetes symptoms.

Saxagliptin and metformin work together to regulate a user’s high blood sugar levels.

Onglyza Side Effects

Onglyza and other incretin mimetics have been linked with the following serious side effects:

• Heart failure
• Thyroid cancer
• Pancreatitis
• Pancreatic cancer
• Acute pancreatitis
• Hemorrhagic pancreatitis
• Necrotizing pancreatitis
• Kidney complications
• Renal failure

Onglyza risk of death may be caused by any one of these more serious side effects, as well as the serious risk of heart failure as noted in the FDA’s review of data.

Onglyza Lawsuits

Some injured consumers have responded by filing lawsuits against the drug’s manufacturers, alleging that they knew or should have known about the increased risk of pancreatic cancer and other side effects, including heart failure, associated with Onglyza.

Onglyza lawsuits claim that the drug’s manufacturers, AstraZeneca and Bristol-Myers Squibb, failed to adequately inform the public and the medical community about the heightened Onglyza risk of death and serious injury. Had they been aware of this risk, plaintiffs claim, they would have chosen a safer alternative.

A lawsuit cannot fix the physical or emotional damage of heart failure or other serious Onglyza side effects, but it can help with the financial losses from medical bills and lost wages. If you have suffered from serious side effects after using Onglyza, you may be able to file a lawsuit.