In 2014, the Food and Drug Administration (FDA) requested clinical trial data from the manufacturer of Type 2 diabetes drugs Onglyza and Kombiglyze XR to review potential heart failure risks. Both drugs are manufactured by AstraZeneca.
It is estimated that approximately 30 million Americans suffer from Type 2 diabetes. Onglyza (saxagliptin) belongs to a class of drugs known as incretin mimetics, which imitate the incretin hormones the body produces to stimulate the release of insulin as part of the digestive process. It works by increasing the level of insulin after meals to reduce blood sugar.
The FDA said that it was reviewing the clinical trial data based on a study published in the New England Journal of Medicine that showed an increased incidence of hospitalization for heart failure among patients on saxagliptin. That study showed a 27% increase in heart failure risk for saxagliptin patients.
A review by the FDA's Endocrinologic and Metabolic Drug Advisory Committee resulted in a recommendation by 14 of the 15 panelists that labeling for Onglyza be updated to include a warning about the potential risks for heart failure. One panelist voted to remove the drug from the market.
Other studies have indicated that Onglyza could increase the risk of chronic pancreatitis, which could lead to pancreatic cancer. In addition, the FDA issued a warning in August 2015 about reported incidents of joint pain in patients taking Onglyza and other Type 2 diabetes drugs that fall into the category of DPP-4 inhibitors.
In October 2015, a lawsuit was filed by a patient's daughter in Illinois alleging that Onglyza caused the death of her mother due to heart failure. Other litigation tied to the use of Onglyza and Kombiglyze XR alleges that AstraZeneca failed to conduct sufficient pre-market trials, failed to warn health care providers and patients about the potential side effects of the drugs and produced fraudulent marketing materials that failed to include information about possible side effects.
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