Cincinnati Product Liability Lawyer reviews new Warning for Diabetes Drugs Onglyza and Nesina


A U.S. Food and Drug Administration (FDA) safety review has found that Adult Type 2 diabetes medicines containing saxagliptin and alogliptin, including Onglyza and Nesina, may increase the risk of heart failure.

In 2014, a study published in the New England Journal of Medicine observed a “higher incidence of hospitalization for heart failure” for patients treated with saxagliptin. As a result, members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended that the FDA supplement such DPP-4 inhibitors Warnings and Precautions labeling to add new safety information. One committee member even voted to remove Onglyza (Saxagliptin) from the market.

Saxagliptin and alogliptin belong to a group of Adult Type 2 diabetes medications called DPP-4 inhibitors. These medicines assist the pancreas in secreting more insulin and stop the liver from making excess sugar.

Onglyza (saxagliptin) was approved by the U.S. Food and Drug Administration (FDA) in 2009. The drug became popular, partly because it effectively controls blood sugar without encouraging weight gain like other diabetes medications.


Risk of Pancreatitis & Onglyza

For years, some doctors have been concerned by reports of a possible increased risk of pancreatitis (inflammation of the pancreas) and cancer associated with incretin-based therapies like Onglyza or Nesina. Some people who have taken these medications have already filed lawsuits against the drugs’ manufacturers after developing pancreatitis or pancreatic cancer, claiming drug companies like AstraZeneca and Takeda failed to properly warn of the risks. Serious cases may lead to hospitalization, pancreatic cancer, or death.

In 2011, after the FDA received reports of patients suffering from acute pancreatitis after taking Onglyza, a potential risk of pancreatitis was added to Onglyza’s official warnings and precautions.

In a 2013 study, researchers found pre-cancerous cells in the autopsied pancreases of people taking incretin drugs. The researchers found small, benign tumors that can become malignant.

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Risk of Onglyza Heart Failure

A 2013 study found a possible link between Onglyza and an increased risk for heart failure. Clinical trials considered in an FDA safety review showed that more patients who received saxagliptin or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment. Risk factors included a history of heart failure or kidney impairment.

Heat failure occurs when the heart pumps blood at a slower-than-usual rate. This prevents the body from receiving the oxygen and nutrients it needs.
Possible side effects of heart failure include the following:

•    Congested lungs
•    Bloating
•    Increased need to urinate
•    Dizziness
•    Fatigue
•    Rapid or irregular heartbeats
•    Unusual shortness of breath
•    Trouble breathing when lying down
•    Weight gain with
•    Swelling in the ankles, feet, legs, or stomach


The editor in chief of the Journal of the American College of Cardiology, Dr. Anthony DeMaria, stated that the drug should be avoided by people at risk for heart failure.

The FDA now recommends that health care professionals consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure. If a patient’s blood sugar level is not well-controlled with their current treatment, they note, other diabetes medicines may be required.


Diabetes Medication Risks

•    Onglyza  (saxagliptin)
•    Kombiglyze XR (saxagliptin and metformin)
•    Nesina (alogliptin)
•    Kazano  (alogliptin and metformin)
•    Oseni (alogliptin and pioglitazone)


The Lyon Firm specializes in drug injury cases and has experience engaging large pharmaceutical companies in drug defect lawsuits. We can work with industry experts to determine the root cause of an injury and build the strongest case possible.

Joe Lyon is a highly-rated Cincinnati recall lawyer and Ohio product liability attorney representing victims of defective drugs nationwide. Call 800.513.2403 for a free consultation.