If left untreated, Type 2 diabetes is a serious and frequently fatal disease that causes high blood pressure, strokes, eye problems, kidney disease, nerve problems and loss of limbs. In 2014, the Centers for Disease Control estimated that there were more than 29 million diabetics in America.
Clearly, drugs that can successfully treat Type 2 diabetes are financial bonanzas for pharmaceutical companies that research and develop these medications. Onglyza (saxagliptin) made $820 million in 2014 for its manufacturer, AstraZeneca.
Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin-metaformin) - both AstraZeneca medications - were highly touted drugs for treating Type 2 diabetes when they received FDA approval in 2009 and 2010. By 2014, the story had changed. The drugs were being associated with an increased risk of heart failure, prompting the FDA to take another look.
But it was not until 2015, that the FDA ordered their labels to include information about the risk of heart failure for patients taking the drugs. Staffers of the federal agency also noted that they were associated with an increase in the rate of “all-cause mortality” based on outcomes of patients in a cardiovascular trial (SAVOR) to determine the drugs’ safety. The study included data from 16,000 patients.
“According to the SAVOR study, Onglyza (saxagliptin) patients were more likely to be hospitalized with heart failure than patients in the control arm. And the increased risk was significant – there was a 27% difference in heart failure hospitalizations between the Onglyza group and the control group.”
Although one FDA panelist wanted to withdraw the saxagliptin drugs from the market after reviewing the SAVOR study, a majority voted to let them remain on the market with a warning about heart failure on their labels.
Onglyza and Kombiglyze are incretin mimetics, drugs that mimic hormones that increase the secretion of insulin. They are only used to treat Type 2 diabetes. Both drugs have hormonal effects on multiple organs including the pancreas. In 2014, the drugs were linked to pancreatitis and pancreatic cancer. The latter is a deadly disease that has no symptoms until it is too advanced to treat.
If you or a loved one were prescribed Onglyza or Kombiglyze, and subsequently developed heart failure, or diseases of the pancreas, you should contact Wayne Wright immediately. Consultations are free. Wayne Wright’s record of legal victories representing clients, who have been injured or died from bad drugs, is outstanding. He has been voted one of the Top 100 Trial lawyers in the U. S. In the last seven years alone, his legal expertise has earned more than $237 million for clients across the United States.