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Onglyza

Patients with type 2 diabetes are usually aware that they are at an increased risk for cardiovascular problems. According to the American Diabetes Association, between 2003 and 2006, cardiovascular disease death rates were about 1.7 times higher among adults with diabetes than among adults without the disease. Heart attack rates were also higher. In 2010, for instance, hospitalization rates for heart attack were 1.8 times higher among adults with diabetes than those without diabetes.

According to the American Heart Association, diabetes greatly increases the risk of heart disease and stroke, because those with diabetes often deal with complications like high blood pressure, cholesterol, and triglycerides, as well as obesity and a sedentary lifestyle. If blood sugar levels are poorly controlled, that increases the risk even more.

Doctors prescribe diabetes medications to help patients keep blood glucose levels within the normal range, which can reduce the risk of cardiovascular disease. Recent studies, however, have shown that many type 2 diabetes medications may actually increase risk of cardiovascular problems.

The concern has grown significantly over the past several years. Just recently, the Food and Drug Administration (FDA) raised red flags about Onglyza (saxagliptin), a type 2 diabetes medication on the market since 2009. In April 2015, an FDA advisory committee recommended that this drug and another similar drug, Nesina, should carry warnings about the potential risk of heart failure.

What is Onglyza?

The FDA approved Onglyza in July 2009, for the treatment of type 2 diabetes. The drug belongs to a class of medications known as “dipeptidyl peptidase-4 (DDP-4) inhibitors,” also called “incretin mimetics,” which stimulate the pancreas to make more insulin after a patient eats a meal. (The popular type 2 diabetes drug “Januvia” is also part of this class.) The extra insulin helps process the glucose to keep levels within a normal range.

The FDA based its approval on the results of eight clinical trials, supplied by manufacturer Bristol-Meyers Squibb Co., and AstraZeneca Pharmaceuticals LP. Among these was a safety study meant to show that Onglyza was not linked to a significant risk of cardiovascular events.

Recently, however, FDA experts analyzed the findings of a clinical trial (the SAVOR study) on Onglyza and heart disease, and found some concerning results. The trial, sponsored by AstraZeneca, involved more than 16,000 participants, all of whom had a history or risk of cardiovascular disease. Some received Onglyza, and some a placebo.

Researchers followed the participants for about two years. Results showed that more patients in the Onglyza group than the placebo group were hospitalized for heart failure—a 27 percent increased risk, to be specific.

These results led to additional FDA scrutiny.

FDA Digs Into Safety Analysis of Onglyza

In February 2014, the FDA issued a drug safety communication indicating that it had requested additional clinical trial data from the manufacturers of Onglyza, “to investigate a possible association between use of the type 2 diabetes drug and heart failure.” They noted at the time that they considered the information from the clinical trial to be preliminary, and wanted to conduct a more thorough analysis after receiving the additional data.

After further analysis, the FDA reported that the heart risk failure reported in the study was valid, and that the study results also indicated a possible increased risk of death from all causes in those patients taking Onglyza. This result popped up when researchers examined data from only patients who took the drug.

The FDA issued a preliminary report indicating their concerns, and scheduled an advisory panel meeting of the Endocrinologic and Metabolic Drugs Advisory Committee for April 14, 2015. The goal of the meeting was to obtain recommendations for how to proceed with these type 2 diabetes drugs.

Panel Recommends Warnings About Heart Failure

The advisory panel reviewed the information, and determined that Onglyza and other similar drugs should carry warnings about their potential to increase risk of heart failure. They also concluded that the drugs did not increase the risk of cardiovascular death, stroke, or heart attack, and did not recommend any restrictions on prescriptions.

The panel downplayed the potential increased risk of death because the participants in the study had died from a number of different causes, and researchers were not able to find a common theme among them. The concern remains, however, and future studies may cast more light on this potential risk.

Fourteen out of fifteen of the FDA advisory panel members recommended that the FDA add new safety information to the labels on these products, with one member voting to withdraw Onglyza from the market because of safety concerns.

Public Citizen Raises the Alarm in 2011

Long before the study came out about Onglyza and the potential increased risk of heart failure, watchdog group Public Citizen had expressed concerns about the drug’s side effects. In an article published in their “Worst Pills Best Pills” newsletter, the group warned consumers that long-term risks of Onglyza had not yet been determined. They expressed concern about the drug’s heart risks, as well as other potential side effects, such as liver toxicity and serious skin reactions.

Januvia, another DDP-4 inhibitor used to treat type 2 diabetes, is on Public Citizen’s “do not use” list because of its potential to increase risk of heart problems and other side effects, like pancreatitis (inflammation of the pancreas).

At the FDA’s advisory committee meeting in April 2015, director of Public Citizen’s Health Research Group, Dr. Sydney Wolfe, addressed the panel and suggested they recall Onglyza from the market. He stated that while the newer drug seemed to have unique risks, it didn’t present any unique benefits to counteract those risks.

Onglyza and Pancreatic Cancer

Perhaps because of how it works to stimulate the release of insulin by the pancreas, Onglyza has also been associated with a potential increased risk of pancreatitis and pancreatic cancer.

A 2013 study, for example, looked at DDP-4 inhibitors and how they affected the pancreas. They found that those patients with type 2 diabetes who were treated with these drugs had an increased risk of enlarged pancreas, and of precancerous cellular changes in the pancreas, indicating a potential increased risk of pancreatic cancer. They added that pre-cancerous growths (tumors) often require surgical removal, and that patients exposed to treatment with drugs like Onglyza “would seem to be at increased risk of requiring pancreatic surgery.”

In March 2013, the FDA released another drug safety communication stating that it was evaluating research that suggested an increased risk of pancreatitis and pre-cancerous cellular changes in patients with type 2 diabetes treated with incretin mimetics. Among the list of drugs at issue were Onglyza, Januvia, Byetta, and Nesina.

In a later 2014 study, researchers examined data from a large clinical trial on Onglyza, and found no increased risk of pancreatitis, and no sign of pancreatic cancer. They recommended additional studies “to completely resolve the pancreatic safety issues with incretin-based therapy.”

Types of Injuries Associated with Onglyza

Onglyza has been linked with the following potential risks:

• Hospitalization for heart failure
• Pancreatic cancer
• Pancreatitis
• Thyroid cancer
• Kidney problems
• Death

In addition to these serious side effects, Onglyza is also associated with the following mild-to-moderate side effects:

• Upper respiratory tract infections
• Urinary tract infections
• Headaches
• Rashes and hives

Onglyza Lawsuits Warranted

The FDA panel’s recommendation to include warnings about the potential increased risk of heart failure on the Onglyza label raises the question: Why wasn’t this warning included on the product when it was released in 2009?

It also means that many patients who took Onglyza were unaware of the potential increased risk, and may have suffered serious side effects as a result. Pharmaceutical companies are responsible for making sure their warnings are complete before releasing a product on the market, to protect the public from unnecessary health issues.

Those patients who took Onglyza and then suffered hospitalization for heart failure may be able to recover damages in court, since the manufacturers failed to provide adequate warnings about this potential outcome.

An Onglyza Lawyer Can Help

If you or a loved one suffered heart failure or hospitalization for cardiovascular problems because of Onglyza, the attorneys at Chaffin Luhana LLP may be able to help. We represent victims nationwide and understand that manufacturers like AstraZeneca and Bristol-Meyers Squibb are responsible for making sure patients and doctors fully understand the risks before taking or prescribing their drugs. When companies fail to do this, they can be held liable for damages that patients suffer.

At Chaffin Luhana, we are well educated in Onglyza’s history and in the studies illustrating its flaws. Call today for a free and confidential case evaluation at 1-888-316-2311.



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