Onglyza and the Risks of Heart Failure and Pancreatic Cancer
Where you or a loved one harmed by Onglyza? This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm
This Type 2 diabetes drug may be associated with some very serious complications, including heart failure, pancreatitis, and pancreatic cancer. The national pharmaceutical practice group of The Michael Brady Lynch Firm is currently evaluating potential Onglyza lawsuits and would like to hear from you if you or someone you care about took Onglyza or Kombiglyze XR and were diagnosed with heart failure or other side effects potentially associated with their use. 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 and work 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. Onglyza was approved by the U.S. Food and Drug Administration (FDA) in 2009, and Kombiglyze XR was approved in 2010. Onglyza sales reached $709 million in 2012, and some analysts believe annual sales of the drug could reach $2.47 billion by 2018.
Just months after the U.S. Food & Drug Administration (FDA) convened an advisory panel meeting to discuss a possible link between Onglyza (saxagliptin) and heart failure, a new analysis indicates that the agency has received at least 19 reports linking the Type 2 diabetes medication with this serious complication. The analysis, which was issued by AdverseEvents, suggests that the FDA’s advisors were on the right track when they recently recommended that the Onglyza label includes 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. The FDA began investigating a possible link between saxagliptin and heart failure in February 2014, when it asked Onglyza’s manufacturer for the raw data from the so-called SAVOR trial.
That study, which followed more than 16,000 patients, was primarily designed to assess cardiovascular outcomes in patients treated with saxagliptin. SAVOR was commissioned after the FDA 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 Onglyza label is updated 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
Mere months after a panel of 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 suggesting that such a link may not exist.
AstraZeneca’s study consisted of an observational, retrospective review of insurance claims that compared patients treated with Onglyza to those who used Januvia or 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), it has yet to be published in a peer-reviewed medical journal.
Onglyza was approved by the FDA in 2009, and last year racked up $820 million in sales.
In February 2014, the FDA issued a safety alert 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 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 the Link to Pancreatic Cancer
According to the FDA, there have been reports of acute pancreatitis in patients taking Onglyza. Saxagliptin should not be prescribed to people who have a history of pancreatitis (inflammation of the pancreas) 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, after a small study linked the drugs to precancerous changes in the pancreas. While no Onglyza lawsuits have been filed over this possible complication, several other incretin mimetic medications are the subject of pancreatic cancer litigation.
If you or a loved one was prescribed Onglyza and suffered heart failure or have been diagnosed with pancreatic cancer, please contact The Michel Brady Lynch Firm for a free evaluation of your case.
About the Firm: The Michael Brady Lynch Firm is a national trial firm with a focus on pharmaceutical mass tort cases involving SSRI and Anti-Seizure Medication Birth Defects including Lexapro, Zoloft, Effexor, Prozac, Celexa, Paxil, Depakote and Topamax, Xarelto bleeding injuries, Mirena IUD, Actos Bladder Cancer, Invokana ketoacidosis, Testosterone heart attack and stroke injuries and medical device cases including DePuy Hip and Trans-Vaginal Mesh cases. Contact us today if you or someone you know has experienced side effects involving these products.