Where you or a loved one harmed by Onglyza? This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm
Researchers associate this Type 2 diabetes drug with some very serious complications. These include heart failure, pancreatitis, and pancreatic cancer. The national pharmaceutical practice group of The Michael Brady Lynch Firm is currently evaluating potential Onglyza lawsuits. We would like to hear from you. If you or someone you care about took Onglyza or Kombiglyze XR and a doctor diagnosed heart failure or pancreatic cancer, contact us. Our attorneys may be able to help you obtain financial compensation for any injury-related damages you incurred, including medical expenses, lost wages, pain and suffering and more.
Onglyza Side Effects
Onglyza or Kombiglyze XR are both DPP-4 inhibitors and belong to a class of Type 2 diabetes medications called incretin mimetics. Both contain the active ingredient saxagliptin. This ingredient works by increasing the amount of incretin released by the intestine. Incretin plays an important role in regulating the amount of insulin secreted by the pancreas. In addition to saxagliptin, Kombiglyze XR also contains metformin and is an extended release medication. The FDA approved Onglyza in 2009 and Kombiglyze XR in 2010. Onglyza sales reached $709 million in 2012. Some analysts believe annual sales of the drug could reach $2.47 billion by 2018.
Months after the FDA convened an advisory panel meeting to discuss a possible link between Onglyza and heart failure. This new analysis indicates that the agency has received at least 19 reports linking the Type 2 diabetes medication with this serious complication. Adverse Events issued the analysis and suggested that the FDA’s advisors were on the right track. The agency recently recommended that the Onglyza label should include information regarding a possible increased risk of heart failure.
Onglyza and Heart Failure
Heart failure is a condition in which the heart cannot pump enough blood to meet the body’s needs. In February 2014, the FDA began investigating a possible link between saxagliptin and heart failure. The agency asked Onglyza’s manufacturer for the raw data from the so-called SAVOR trial.
Researchers designed the study with 16,000 participants to assess cardiovascular outcomes in patients treated with saxagliptin. Then, the FDA commissioned SAVOR after the agency embarked on a larger investigation into the safety of diabetes drugs. The findings of SAVOR suggested that those exposed to Onglyza were 27% more likely to be hospitalized for heart failure compared to those treated with a placebo.
In April, FDA advisors overwhelmingly recommended that the manufacturer update Onglyza label to reflect these findings. While the FDA is not required to follow the recommendations of its advisory panels, it usually does so.
Manufacturer Disputes Findings with Bogus Study
Months after health experts called for new label warnings regarding a possible link between Onglyza and heart failure, the manufacturer of the Type 2 diabetes drug released new research. Their research suggested a link may not exist. AstraZeneca’s study consisted of an observational, retrospective review of insurance claims. These claims compared patients treated with Onglyza to those who used Januvia. Januvia is a class of diabetes medications called sulfonylureas, such as metformin. Findings suggested that Onglyza and Januvia patients faced a lower risk of heart failure compared to those taking sulfonylureas.
While AstraZeneca presented the study in June at a meeting of the American Diabetes Association (ADA), a peer-reviewed medical journal is yet to publish it.
In February 2014, the FDA issued a safety alert. This was after a clinical trial published in the New England Journal of Medicine linked Onglyza to a 27% increased risk of hospitalization for heart failure. The goal of the 16,492-patient study was to see if saxagliptin could provide heart-protective benefits. This is in addition to controlling blood glucose levels. In April 2015, the FDA convened an advisory panel meeting to further investigate the link between Onglyza and heart failure. The panel voted 14-1 to recommend that new safety information regarding an increased risk of heart failure be added to the labels of both Onglyza and Kombiglyze XR.
Onglyza and Pancreatic Cancer
According to the FDA, there have been reports of acute pancreatitis in patients taking Onglyza. Medical professionals should not prescribe saxagliptin to people who have a history of pancreatitis (inflammation of the pancreas). This is because it is not known whether the medication can increase the risk for the disease. In 2013, the FDA also launched an investigation of incretin mimetics like Onglyza and pancreatic cancer. This was after a small study linked the drugs to precancerous changes in the pancreas. While plaintiffs have not filed any Onglyza lawsuits over this possible complication, several other incretin mimetic medications are the subject of pancreatic cancer litigation.
If a doctor prescribed you or a loved one Onglyza and you suffered heart failure or a doctor diagnosed you with pancreatic cancer, please contact The Michel Brady Lynch Firm for a free evaluation of your case.