Onglyza Lawsuit
(Saxagliptin)
Problem summary
Former Onglyza users are suing AstraZeneca and former partner Bristol-Myers Squibb over potentially life-threatening cardiac complications and other major medical issues allegedly caused by the diabetes drug. Although Onglyza was considered safe at the time it was approved in 2009, a growing body of evidence suggests that the diabetes medication may put users risk for serious side effects, namely cardiovascular problems, which can be fatal.
As one Onglyza lawsuit filed in 2017 stated, “At no time during the development of its saxagliptin drugs did Defendants perform adequate studies to determine if their drug, and its drastic alterations of the natural incretin hormone cycle, may cause increased risk of cardiovascular related adverse events. Such studies are essential when developing, and then marketing, diabetic drugs to individuals already at an increased cardiovascular risk.” The fact that Onglyza may put patients at risk for cardiac arrest and heart failure is particularly alarming, considering the FDA issued guidance in 2008 requiring drug companies to conduct research to demonstrate that any new diabetes medications do not increase cardiovascular risk.
About Onglyza
Onglyza (saxagliptin) is a diabetes medication manufactured by AstraZeneca and approved by the FDA in 2009 to treat Type 2 diabetes in adults. Onglyza belongs to a class of diabetes drugs called incretin mimetics, which work by mimicking the incretin hormones in the body to trigger a release of insulin after the person eats. Although people with Type 2 diabetes can make insulin, their cells don’t use it as well as they should to control their blood sugar levels, a condition known as insulin resistance. Onglyza, an active DPP-4 (dipeptidyl-peptidase 4) inhibitor, assists the pancreas with insulin creation and helps control blood sugar levels by regulating the body’s insulin levels after meals.
For some time, the most serious health concern linked to Onglyza use was pancreatitis possibly leading to pancreatic cancer. In a 2013 study published in the medical journal Diabetes, researchers found that diabetes patients taking Onglyza and other incretin mimetic drugs showed an increase in abnormal pancreatic growths and precancerous cell changes. More recently however, there has been increasing evidence suggesting a link between Onglyza and heart failure, a condition characterized by the heart’s inability to pump enough blood to fulfill the body’s needs, and this is now the primary focus for Onglyza lawsuits.
In 2014, the FDA performed a safety review into potential Onglyza heart risks following a study by the New England Journal of Medicine, which found a higher-than-expected rate of hospitalizations for heart failure among patients taking the diabetes drug. The following year, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee called for stronger warnings on the Onglyza label regarding the potential risk of heart failure from the diabetes treatment. Despite growing concerns about the safety of Onglyza use, it wasn’t until April 2016 that the FDA required stronger heart failure warnings on the drug label and the potential risk of heart failure from Onglyza treatment was finally revealed to the public.
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Onglyza Side Effects
- Cardiac arrest
- Heart attack
- Congestive heart failure
- Cardiovascular problems
- Pancreatitis
- Pancreatic cancer
- Thyroid cancer
- Hypoglycemia
- Joint pain
- Wrongful death
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Onglyza Settlements & Litigation
Many Onglyza users and their loved ones have taken legal action against AstraZeneca and Bristol-Myers Squibb, filing legal claims in state and federal courts across the country, and in February 2018, all federal lawsuits brought against the drug makers were consolidated in a multidistrict litigation (MDL) in the Eastern District of Kentucky. Plaintiffs in the Onglyza litigation allege that the drug makers started marketing Onglyza in 2009, before adequately testing the drug to determine whether it increased patients’ cardiac risks, ignoring the FDA’s 2008 guidance regarding the safety of new diabetes drugs. Lawsuits also claim that AstraZeneca and Bristol-Myers Squibb knew about the heart-related side effects allegedly associated with Onglyza treatment, yet failed to adequately warn the public and the medical community about this risk, accusing the drug manufacturers of negligence, breach of warranties and failure to warn.
If you or a loved one has suffered heart failure or another serious side effect you believe to be related to Onglyza treatment, you may be entitled to compensation for medical expenses, pain and suffering, lost wages, loss of enjoyment of life, loss of consortium, and other damages.
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