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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, along with Metformin. 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.
