A dangerous drug lawsuit has been filed in Texas against drug manufacturers AstraZeneca and Bristol- Myers Squibb after a man taking the drugs suffered congestive heart failure. He’d been prescribed Onglyza and Kombiglyze XR (saxagliptin and metformin extended release) between 2010 and 2015 to treat his diabetes. Onglyza and Kobiglyze XR belong to a class of drugs known as DPP-4 inhibitors that work to control blood sugar by helping the pancreas to produce more insulin after meals and reducing the amount of glucose produced by the liver.
The lawsuit alleges negligence, manufacturing a defective product and failure to warn of the risks associated with the drugs. The FDA approved Onglyza in 2009 and Kombiglyze in 2010.
Unlike other Type-2 diabetes drugs, Onglyza and Kombiglyze don’t cause weight gain. However, the FDA has recognized the drugs contain significant side effects. “FDA evaluated two large clinical trials conducted in patients with heart disease,” the agency wrote. “These clinical trials were also discussed at the FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting in April 2015. Each trial showed that more patients who received saxagliptin- or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo.” The FDA-reviewed cardiovascular outcomes trial referred to as SAVOR has found that patients prescribed Onglyza are far more likely to experience heart failure than others diagnosed with diabetes. The study found a 27 percent increase in first-time hospitalization rates for those taking Onglyza. Additionally, the study noted a significant increase in all-cause mortality. Not only is Onglyza linked with heart failure, multiple reports indicate that it and other DPP-4 inhibitors may lead to chronic pancreatitis, which, in turn, may result in pancreatic cancer. One particularly compelling study conducted by researchers at UCLA indicates that patients who undergo incretin therapies (such as taking Onglyza) may experience abnormal pancreatic growths.
In 2016, Astra Zeneca added heart failure to the list of potential complications for its drug.
In addition to heart failure, the FDA linked saxagliptin to pancreatitis and possible pre-cancerous pancreas cells in 2013. Then, in 2015, it issued another safety communication warning that DPP-4 drugs including Onglyza could increase the risk of severe joint pain.
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