This mass tort investigation alleges that the diabetes drug Onglyza can raise the risk of pancreatic cancer in patients and cause heart failure and death. Onglyza is made by AstraZeneca and has been approved by the FDA for the treatment of Type 2 diabetes.
Onglyza (also known as saxagliptin) is part of a new class of drugs that are intended to lower glucose levels and reduce diabetic complications. It has become a popular drug for the treatment of Type 2 diabetes and by 2011 had earned more than $700 million in sales.
Onglyza is an “incretin mimetic,” which means that it mimics the natural incretin hormones that the body creates to stimulate the release of insulin after a meal. However, a 2013 study of incretin mimetics published in the medical journal Diabetes found evidence of increased pancreatic mass and precancerous cells in users. This suggests that these drugs may increase the risk of chronic pancreatitis, which may lead to pancreatic cancer.
Onglyza was approved by the FDA in 2009. The previous year, the FDA had announced new guidelines for Type 2 diabetes drugs, saying that “companies should conduct a more thorough examination of their drugs’ cardiovascular risks during the product’s development stage.” The statistics from Onglyza’s studies met the new guidelines, but the FDA was not convinced that the studies themselves were of sufficient quality. It approved Onglyza but required that AstraZeneca conduct a more stringent study on the drug’s cardiovascular safety.
The results of this study were published in 2013 in the New England Journal of Medicine. It found that patients taking saxaglyptin had an increased rate of hospitalization for heart failure, as well as an increased risk of death overall.
As a result, the FDA began looking into data on Onglyza and heart problems. In April 2015, it required that AstraZeneca place a warning on its label that warns patients of an increased risk of heart failure from taking the drug.
This mass tort investigation alleges that AstraZeneca waiting until after it had obtained FDA approval to do adequate testing on Onglyza. It claims that AstraZeneca therefore withheld important information about the hazards of taking the drug from both the FDA and the general public, and that many thousands of patients have therefore been unknowingly exposed to higher risks of cancer, heart failure, and death.