Another lawsuit was recently filed in the US District Court for the Northern District of Georgia alleging that a Georgia woman suffered heart failure that was caused by the diabetes drug Onglyza. The complaint, which was filed against the drug makers AstraZeneca and Bristol-Myers Squibb on July 24, claims that the drug was defective because it failed to adequately warn consumers and the healthcare community about the risks of heart failure when taking the drug. The complaint was filed on behalf of Cynthia Turner who alleged she took the medication from 2013 to 2014 and it caused her to develop heart failure, congestive heart failure and other cardiac injuries.
The Complaint specifically alleges:
Defendants marketed, promoted, distributed, and sold unreasonably dangerous and defective prescription Saxagliptin to health care providers empowered to prescribe and dispense to consumers, including Plaintiff, without adequate warnings and other clinically relevant information and data. Through both omissions and affirmative misstatements, Defendants misled the medical community about the risk/benefit balance of Saxagliptin, which resulted in injury to Plaintiff
View the full version of the filed complaint HERE.
Onglyza was developed by AstraZeneca and Bristol-Myers Squibb and approved by the FDA in July 2009 for the treatment of type 2 diabetes. The FDA launched an investigation concerning Onglyza and potential cardiac risks associated with the drug after the publication of the SAVOR study by the New England Journal of Medicine in 2013. Read more about the SAVOR study HERE. Ultimately the FDA required the makers of the drug to add warnings to the labels of all saxagliptin-based drugs, including Onglyza, warning patients and their doctors that the drug may cause heart failure.
The FDA’s actions came after an in-depth evaluation of the studies and clinical data linking Onglyza to congestive heart failure. In April 2015 the FDA’s FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 for stronger warnings to be added to the drugs labeling about the cardiac risks. Read more about the FDA’s investigation HERE. Their review included looking at two large clinical trials involving patients with heart disease that found the saxagliptin or alogliptin groups were at a higher risk of being hospitalized for heart failure than the placebo group.
These risks are particularly important to healthcare providers and patients when doing a risk/benefit analysis to determine the most effective and safest drug for a particular patient. The Turner complaint is similar to a growing number of other complaints alleging that AstraZeneca and Bristol-Myers Squibb failed to warn patients and the medical community of the heart failure risks associated with Onglyza. Read more about the other lawsuits filed HERE.
If you or a loved one have suffered heart failure, congestive heart failure, cardiac complications or death while taking ONGLYZA or KOMBIGLYZE XR to treat type 2 diabetes you may be entitled to compensation. Please contact us today.
There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner. Your state of residence, when you ingested the drug and when you experienced injuries could all affect how much time you have to file.
Complete the form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
Melissa Fry Hague
If you believe you or a loved one may have an Onglyza claim, contact us today. One of our attorneys will contact you within 24 hours to conduct a free and confidential evaluation of your case.
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The U.S Food and Drug Administration (FDA) has announced that taking medications containing saxagliptin or alogliptin, such as ONGLYZA or KOMBIGLYZE XR, may increase your risk of heart failure, especially if you already have heart or kidney disease. The announcement came at the end of the FDA’s Safety Review in which it analyzed the results of two large clinical trials that evaluated the risks of heart disease in those taking such medications. The announcement was particularly alarming, given that ONGLYZA and KOMBIGLYZE XR are marketed to diabetics to help control their blood sugar, and those with diabetes are already at a greater risk of developing heart disease.
The FDA’s safety review included its evaluation of two large clinical trials conducted on patients with heart disease. Some of the patients were given medications containing saxagliptin or alogliptin, such as ONGLYZA or KOMBIGLYZE XR, while other received a placebo. The results of these trials were discussed during the agency’s Endocrinologic and Metabolic Drugs Advisory Committee meeting in April 2015.
Both trials showed that more patients who received ONGLYZA or KOMBIGLYZE XR, or another saxagliptin or alogliptin medication, were hospitalized for heart failure compared to patients who received a placebo. More information on these trials can be found here.
As a result of the FDA’s Safety Review, the agency advised patients taking ONGLYZA or KOMBIGLYZE XR, and other saxagliptin or alogliptin medications to immediately contact their health care providers if they develop signs or symptoms of heart failure such as:
The FDA also warned health care professionals to consider discontinuing ONGLYZA or KOMBIGLYZE XR, and other saxagliptin or alogliptin medications in patients who develop heart failure and to monitor their diabetes control.
According to the FDA, in 2015, approximately 386,000 patients received a dispensed prescription for saxagliptin-containing products, such as ONGLYZA or KOMBIGLYZE XR, from the U.S. outpatient retail pharmacy setting.
As a result of its safety review the FDA mandated that new warnings be placed on drug labels for ONGLYZA, KOMBIGLYZE XR and other saxagliptin or alogliptin medications.
The new labels now specifically warn patients and doctors about the increased risks associated with heart disease and taking ONGLYZA or KOMBIGLYZE XR. For example, each new ONGLYZA label now states:
Heart Failure: Consider the risks and benefits of ONGLYZA in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. (5.2)
5.2 Heart Failure
In a cardiovascular outcomes trial enrolling participants with established ASCVD or multiple risk factors for ASCVD (SAVOR trial), more patients randomized to ONGLYZA (289/8280, 3.5%) were hospitalized for heart failure compared to patients randomized to placebo (228/8212, 2.8%). In a time-to-first-event analysis the risk of hospitalization for heart failure was higher in the ONGLYZA group (estimate Hazard Ratio: 1.27; 95% Cl: 1,07, 1.51). Subjects with a prior history of heart failure and subjects with renal impairment had a higher risk for hospitalization for heart failure, irrespective of treatment assignment.
Consider the risks and benefits of ONGLYZA prior to initiating treatment in patients at a higher risk for heart failure. Observe patients for signs and symptoms of heart failure during therapy. Advise patients of the characteristic symptoms of heart failure and to immediately report such symptoms. If heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of ONGLYZA.
If you or a loved one have suffered heart failure, congestive heart failure, cardiac complications or death while taking ONGLYZA or KOMBIGLYZE XR to treat type 2 diabetes you may be entitled to compensation. Please contact us today.
There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner. Your state of residence, when you ingested the drug and when you experienced injuries could all affect how much time you have to file.
Complete the form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
Melissa Fry Hague
If you believe you or a loved one may have an Onglyza claim, contact us today. One of our attorneys will contact you within 24 hours to conduct a free and confidential evaluation of your case.
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In October 2013 The New England Journal of Medicine reported on a large, randomized, double-blind, placebo-controlled postmarketing study designed to evaluate the cardiovascular effects of Onglyza and Kombiglyze in adult patients with type 2 diabetes mellitus. The SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial was conducted as a result of the 2008 FDA guidance, Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. This guidance mandated that sponsors of new antidiabetic therapies used to treat type 2 diabetes establish the safety of those drugs by ensuring they are not associated with an unacceptable increase in cardiovascular risk.
Diabetes Mellitus has become a widespread epidemic in the United States. It is a chronic metabolic disorder characterized by hyperglycemia caused by defective insulin secretion, resistance to insulin action, or a combination of both. The leading cause of mortality among this patient population is cardiovascular disease. As such, the mortality rates associated with diabetes accounts for a substantial portion of health care expenditures. In an effort to reduce these risks and the healthcare costs associated with them, the FDA set forth recommended development programs for new clinical studies for new type 2 antidiabetic therapies.
In accordance with this guidance, AstraZeneca and Bristol-Myers Squibb funded the SAVOR-TIMI 53 clinical trial which looked at the increased risk of cardiovascular disease among patients with type 2 diabetes, who had a history of or were at risk for cardiovascular events, and were taking Saxagliptin (the active ingredient in Onglyza and Kombiglyze). The results of the clinal trial were published in the New England Journal of Medicine and found saxagliptin treatment was associated with an increased risk for hospitalization for heart failure. Scirica, Benjamin M. et al., Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus, N. Engl. J. Med., 369;14, October 3, 2013. This increased risk was highest among patients with elevated levels of natriuretic peptides, prior heart failure, or chronic kidney disease.
The SAVOR clinical trial involved 16,492 patients with type 2 diabetes who were randomly selected to receive saxagliptin or a placebo and were followed for a median of 2.1 years. The primary endpoint for the trial cohort was cardiovascular death, myocardial infarction, or ischemic stroke. More patients in the saxagliptin group than in the placebo group were hospitalized for heart failure (3.5% vs. 2.8%, according to 2-year Kaplan–Meier estimates; hazard ratio, 1.27; 95% CI, 1.07 to 1.51; P=0.007). Also noteworthy, significantly more patients in the saxagliptin group than in the placebo group reported at least one hypoglycemic event (1264 patients [15.3%] vs. 1104 patients [13.4%], P<0.001); major hypoglycemic events occurred in 177 patients (2.1%) in the saxagliptin group as compared with 140 patients (1.7%) in the placebo group (P=0.047).
Another large clinical trial, EXAMINE, The Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome, found results similar to that of the SAVOR clinical trials with alogliptin, another DPP-4 class drug. EXAMINE was also a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 5,380 patients with type 2 diabetes who had established cardiovascular disease with a recent acute coronary syndrome event. Significantly more patients randomized to the alogliptin group in this clinical trial also experienced at least one hospitalization for heart failure compared to patients randomized to the placebo group.
As a result of these clinical trials The FDA conducted a safety review concerning drugs antidiabetic drugs containing saxagliptin, including Onglyza and Komgiblyze, and ultimately mandated a label change warning users and prescribers of these medications of the increased cardiovascular risks. Read more about the FDA warnings and changes in the warning labels for these drugs HERE.
If you or a loved one have suffered heart failure, congestive heart failure, cardiac complications or death while taking ONGLYZA or KOMBIGLYZE XR to treat type 2 diabetes you may be entitled to compensation. If you believe you or a loved one may have a claim, contact us today.
There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner. Your state of residence, when you ingested the drug and when you experienced injuries could all affect how much time you have to file.
Complete the form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
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If you believe you or a loved one may have an Onglyza claim, contact us today. One of our attorneys will contact you within 24 hours to conduct a free and confidential evaluation of your case.
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Pharmaceutical giants AstraZeneca and Bristol-Meyers Squibb are facing lawsuits filed by patients who experienced heart problems after taking prescription drugs Onglyza and Kombiglyze XR to help manage their type 2 diabetes. The active ingredient in both Onglyza and Kombiglyze XR is saxagliptin, a DPP-4 inhibitor that helps lower blood glucose levels. Studies have shown that patients taking Onglyza and Kombiglyze XR face an increased risk of hospitalization for heart failure.
The first case against AstraZenica relating to Onglyza lawsuit was filed in October 2015 by a Chicago woman who alleged that Onglyza led to her mother’s death. It was filed in Cook County Circuit Court on behalf of the estate of Lillie Ree Gibson and alleges that Ms. Gibson began taking Onglyza in 2010 upon doctor’s orders, which led to her heart problems and subsequent death on Oct. 31, 2013. The suit says she was diagnosed with heart failure in June 2011, and was hospitalized twice in 2013 for her heart condition before she passed away. Ms. Gibson’s family filed the lawsuit seeking damages and attorney’s fees.
In February 2017, Texas resident Wrendell Chester filed a heart failure lawsuit against AstraZeneca and Bristol-Meyers Squibb. According to the lawsuit, Chester developed severe complications after ingesting saxagliptin from 2010 to 2015, including heart failure, congestive heart failure, and acute hypoxic respiratory failure. According to the lawsuit, AstraZeneca and Bristol-Meyers Squibb failed to warn Mr. Chester, other patients, consumers and medical providers about any potentially life-threatening side effects before they took or prescribed the drug. The lawsuit says AstraZeneca’s marketing over-promoted Onglyza and Kombiglyze XR and downplayed the drugs’ risks.
In May 2017, fourteen New Jersey plaintiffs with near-identical Onglyza and Kombiglyze XR lawsuits consolidated their litigation efforts against AstraZeneca and Bristol-Meyers Squibb. Some of the New Jersey cases were originally filed in San Francisco, but re-filed in New Jersey after the San Francisco judge granted a motion to sever and dismiss non-California plaintiffs from the case. It is believed there are approximately 150 lawsuits pending across the country seeking damages against AstraZeneca and Bristol-Meyers Squibb for the potentially life-threating harm suffered by patients who took Onglyza or Kombiglyze XR.
Bristol-Meyers Squibb received Food and Drug Administration approval for Onglyza in July 2009 without undergoing any premarket cardiovascular risk tests, despite a strong recommendation by the FDA in 2008 that new diabetic therapies undergo such a risk assessment before approval. The FDA approved Kombiglyze XR in 2010. In 2014, AstraZeneca acquired Bristol-Meyers Squibb’s diabetes drug portfolio.
On February 11, 2014, the FDA issued a Safety Communication announcing it was investigating a possible increased risk for heart failure for patients taking Onglyza and Kombiglyze XR following a study published in the New England Journal of Medecine reporting on a clinical study that found an increased rate of hospitalization for heart failure in patients taking saxagliptin over patients in a control group.
On April 5, 2016, the FDA issued a Safety Announcement that drugs containing saxagliptin (Onglyza and Kombiglyze XR), may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. Onglyza’s label was revised in February 2017 to add the risk of heart failure as a Warning and Precaution.
If you or a loved one have suffered heart failure, congestive heart failure, cardiac complications or death while taking ONGLYZA or KOMBIGLYZE XR to treat type 2 diabetes you may be entitled to compensation. Please contact us today.
There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner. Your state of residence, when you ingested the drug and when you experienced injuries could all affect how much time you have to file.
Complete the form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
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Onglyza (Saxagliptin) is a prescription medication used to help manage blood glucose levels in individuals with type 2 diabetes. Diabetes mellitus type 2, also known as type 2 diabetes, is a chronic metabolic disorder that is characterized by high blood sugar, insulin resistance, and relative lack of insulin. Although some diabetics can control their blood glucose levels with diet and exercise, many are prescribed pharmaceuticals to help manage the disease.
Pharmaceutical giants, AstraZeneca and Bristol-Myers Squibb teamed up to develop, manufacture and market Onglyza, which received FDA approval for the treatment of type 2 diabetes in 2009.
Onglyza has been an extremely profitable venture and generated more than $700 million in sales in 2012 alone.
Onglyza is a member of a class of medications known as dipeptidyl peptidase-4 (“DDP-4”) inhibitors. When non-diabetics ingest carbohydrates, which break down in the body to become glucose, it triggers the release of incretins. Incretins produce and regulate insulin in the body. The release of insulin allows the glucose in the blood stream to move to the cells of the body, where it is used and expelled as energy.
This process is disrupted in individuals with type 2 diabetes. Although type 2 diabetics may produce incretins, the enzyme DPP-4 effectively destroys the incretin hormone before it can trigger the production and regulation of insulin. The result is that the glucose remains in the blood stream and the individual’s blood glucose level goes up.
DPP-4 inhibitors, like Onglyza and Kombiglyze XR, work by blocking or “inhibiting” the actions of the DPP-4 enzyme. This allows the incretin hormones in their body to work properly and release insulin from the pancreas in response to a meal.
The active ingredient in Onglyza is saxagliptin. Two large clinical studies recently showed that patients who received saxagliptin- or alogliptin-containing medicines were hospitalized for heart failure more than those who received a placebo. In addition to Onglyza, AstraZeneca also distributes Kombiglyze XR, which is also a DDP-4 inhibitor that contains saxagliptin as one of its active ingredients. Those clinical studies that were recently conducted showed serious cardiac risks associated with Onglyza and Kombiglyze XR and have raised concerns about the risks associated with use of the drug.
Public Citizen, a consumer watchdog group, questioned the safety of Onglyza as early as 2011, shortly after the drug received FDA approval in 2009. In a newsletter article, Public Citizen expressed their concerns over the lack of long-term data available on the drug and urged consumers to not take Onglyza until such studies were conducted.
In October 2013, the New England Journal of Medicine (NEJM) published a study in which a connection between the use of saxagliptin and increased risk of cardiovascular events was identified. The study found that “[s]axagliptin was associated with significantly improved glycemic control and reduced the development and progression of microalbuminuria; however, it increased the risk of hospitalization for heart failure and the risk of hypoglycemic events.”
In February 2014, the FDA responded to the NEJM article by issuing a drug safety communication which made public the FDA’s request that the manufacturer of saxagliptin provide clinical trial data for the purpose of investigating the potential link between the drug and increased risk of heart failure.
In April 2015, the FDA Endocrinology and Metabolic Drugs Advisory Committee voted by an overwhelming majority (14 to 1) to update the Onglyza label to include stronger warnings about the higher risk of heart failure associated with the drug’s use.
During their discussion, the FDA panelists noted that patients taking this class of drugs had a 27% increase in the rate of hospitalization for heart failure and an overall increased risk of death, regardless of cause. One panelist felt that a labeling change was not sufficient and voted in favor of completely withdrawing the drug from the U.S. market.
The FDA then issued a drug safety communication which required heart failure warnings be included on the labels for Onglyza and Kombiglyze XR, as well as all other DDP-4 inhibitors.
In April 2016, AstraZeneca updated the Onglyza prescribing information to include warnings about the increased risk of pancreatitis and heart failure. In early 2017, warnings regarding the increased risk of bullous pemphigoid, a rare skin disorder, and macrovascular outcomes were also added.
Onglyza users have reported the following adverse events:
The FDA Endocrinology and Metabolic Drugs Advisory Committee has also advised that individuals with a prior history of heart failure and/or renal insufficiency have a higher risk of experiencing a serious adverse event when using DDP-4 inhibitors.
Individuals who have suffered an injury after using Onglyza are generally filing lawsuits that assert that the manufacturers:
Currently, individuals alleging injuries caused by their use of Onglyza are filing individual lawsuits against the AstraZeneca, Bristol-Myers Squibbs and, in cases of Kombiglyze XR use, McKesson Corporation.
These lawsuits are still in the very early phases of litigation and have not been consolidated into a Multi-District Litigation (“MDL”) or a class action litigation.
If you or a loved one used Onglyza or Kombiglyze XR for the treatment of type 2 diabetes and then suffered from congestive heart failure, cardiac failure or death, you may be entitled to compensation.
If you believe you may have a claim, contact us today. There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner. Your state of residence, when you ingested the drug and when you experienced injuries could all affect how much time you have to file.
Complete the form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
Melissa Fry Hague
If you believe you or a loved one may have an Onglyza claim, contact us today. One of our attorneys will contact you within 24 hours to conduct a free and confidential evaluation of your case.
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If you or a loved one have suffered heart failure, congestive heart failure, cardiac complications or death while taking Onglyza or Kombiglyze XR to treat type 2 diabetes you may be entitled to compensation.
Onglyza (Saxagliptin) and Kombiglyze XR are prescription medications used to treat type 2 diabetes to help manage blood glucose levels. Two large clinical studies conducted on patients with heart disease showed that patients who received saxagliptin- or alogliptin-containing medicines were at a higher risk of heart failure compared to patients who received an inactive placebo treatment. The findings of the SAVOR trial were first reported in August 2013, which showed a 27% increase in the risk of hospitalization for heart failure among Onglyza users. In the saxagliptin and alogliptin trials, patients who received the drug were hospitalized at a higher rate that those receiving the placebo. Risk factors included a history of heart failure or kidney impairment.
Onglyza users have also reported other adverse events including:
⊕ Read more about Onglyza and the current litigation here.
If you believe you or a loved one may have a claim, contact us today. There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner. Your state of residence, when you ingested the drug and when you experienced injuries could all affect how much time you have to file.
Complete the form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
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