Onglyza (saxagliptin) is an oral medication used to treat type 2 diabetes. This prescription drug is a DPP-4 (dipeptidyl peptase-4) inhibitor and is considered an incretin mimetic drug.

The type 2 diabetes medication works by allowing more insulin release by stimulating the pancreas; It has been FDA approved since 2009.

Patients and physicians alike have had concerns over the years about the safety of Onglyza. Recently, the FDA stepped in to investigate some of the claims of harmful Onglyza side effects that were brought against the drug’s maker.

FDA Reviews Onglyza Heart Failure Claims

Members of the Endocrinologic and Metabolic Drugs Advisory Committee were invited by the FDA to participate on a special advisory panel. This FDA advisory panel would determine any Onlyza safety risks by examining the available research that has performed on type 2 diabetes drug.

The biggest Onglyza study, called “SAVOR,” was published in 2013 and involved more than 16,000 participants. The results of the study found that those who took Onglyza had a 27 percent increased risk of hospitalization versus patients taking a placebo.

After reviewing the SAVOR study results, the FDA conducted their own study entitled “EXAMINE” and determined that the concerns over an increased risk of hospitalization due to Onglyza heart failure were indeed valid. In addition to hospitalization, the FDA found that there was an increased risk of death as well, though specific conclusions into the nature of the increased risk were not determined.

After reviewing relevant research, the panel came to the conclusion that the FDA should require Onglyza’s drugmakers AstraZeneca and Bristol-Meyers Squib to update their drug labels with more detailed safety warnings about heart failure side effects.

Other Side Effects of Onglyza

Along with other incretin drugs used for type 2 diabetes, Onglyza has been linked to an increased risk of developing pancreatic cancer. Since Onglyza stimulates the pancreas, it can also cause inflammation, enlargement and changes in the cells of the pancreas that are considered pre-cancerous.

There have been conflicting results in studies, however, about the link between Onglyza use and pancreatic cancer. A 2013 study showed there was an increased risk of pancreatic changes and problems, while a 2014 Onglyza study delivered mixed results.

The FDA has maintained that they will continue to study the drug and monitor the connection between Onglyza use and pancreatic changes.

Pancreatic Cancer and Heart Failure Symptoms

Due to the sometimes unclear nature of symptoms of both pancreatic cancer and heart failure, these conditions may be hard to detect. With pancreatic cancer, symptoms may be very general at first and the disease may not become obvious until the cancer has progressed to a late stage.

Heart failure, especially in a person with type 2 diabetes, may also be misdiagnosed. Many doctors and patients alike may incorrectly assume the symptoms of heart failure are due to a patient being overweight.

Some common symptoms to look out for with respect to pancreatic cancer include:

• Abdominal pain
• Diarrhea
• Nausea
• Bloating
• Pale stools
• Weight loss
• Loss of appetite
• Itching all over

Signs of congestive heart failure include

• Getting tired easily
• Shortness of breath
• Weakness
• Swelling in legs, ankles and feet
• Inability to exercise
• Sudden weight gain
• Increased nighttime urination
• Rapid or irregular heartbeat

Onglyza Lawsuit Information

If you or a loved one has suffered heart failure, pancreatic cancer or other problems of the pancreas, or a loved one has died following the use of Onglyza, you may have a legal claim. An experienced Onglyza lawyer can guide you regarding your legal options in a free, confidential consultation.