The FDA requested that the makers of the Type II Diabetes drugs, Onglyza and Kombiglyze XR (generic: saxagliptin)—AstraZeneca Pharmaceuticals LP and Bristol-Myers Squibb Company—conduct a clinical trial to look into a potential tie between the use of these drugs and heart failure. Onglyza received FDA approval in 2009; Kombiglyze XR was approved in 2010.
Incretin mimetic medications, such as Onglyza and Kombiglyze XR, two Type II diabetes medications, have already been associated with various adverse health reactions, especially to the pancreas, including pancreatitis, which is a known precursor to pancreatic cancer.
Parker Waichman is investigating potential lawsuits on behalf of patients who were injured due to the Type 2 diabetes medications, Onglyza and Kombiglyze.
Lawsuits Mounting Over Onglyza and Kombiglyze
According to May 2017 report from The National Law Journal revealed, between 150 and 200 product liability lawsuits have been filed against AstraZeneca Pharmaceuticals and Bristol-Myers Squib over Onglyza and Kombiglize XR.
Plaintiffs allege that AstraZeneca Pharmaceuticals and Bristol-Myers Squib were aware that saxagliptin, the main ingredient in the medications, might raise a patient’s risk of heart failure, yet failed to provide doctors and patients with sufficient warnings concerning this potential danger. Plaintiffs seek to recover compensation for medical bills, lost wages, pain and suffering, emotional distress, and more.
California Federal Judge Remands Onglyza Lawsuit to State Court, Finds Distributor Claims Potentially Viable
In April 2017, a California federal judge remanded an Onglyza lawsuit to state court after learning that the claims made against distributor, McKesson Corp., could be feasible. The case was first filed in May 2016 in San Francisco County Superior court, according to HarrisMartin.com. The case alleged that McKesson Corp. and Onglyza’s manufacturer misrepresented the drug’s safety and of allegedly hiding ties with the drug and congestive heart failure, cardiac failure, and other adverse side effects.
Defendants moved the lawsuit to federal court as the court had subject matter jurisdiction due to the diversity of the involved parties. The defendants argued that McKesson was fraudulently joined to obliterate complete diversity. The plaintiff moved to remand, alleging that it was impossible for McKesson to prove its allegations, as sufficient discovery had not yet taken place.
In ruling for the plaintiff, Judge Jon S. Tigar of the U.S. District Court, Northern District of California, found that the matter raised “complex issues of state law” to be decided at the state level. “California law remains unsettled on the question of whether a plaintiff may bring a strict liability action against a distributor who is not part of the vertical chain of distribution that provided a plaintiff with the product that caused him or her harm,” Judge Tigar wrote in his April 24th order. “Similarly here, whether McKesson remains liable under Plaintiff’s strict liability theory remains a question properly decided by the state court,” Judge Tigar concluded. “That a defendant might be dismissed, particularly after a close call in an evolving area of state law, does not mean that the defendant was fraudulently joined. Rather, these are ‘complex issues of state law’ that should be decided in the first instance by state, not federal, courts.”
Over One-Dozen Lawsuits Brought in New Jersey
In early May 2017, a total of 14 lawsuits were brought against AstraZeneca Pharmaceuticals and Bristol-Myers Squibb in the District of New Jersey over allegations that users of saxagliptin drugs face increased risks of heart failure. The plaintiffs also allege that the drug makers did not warn that Onglyza and Kombiglyze XR might lead to cardiac arrest, congestive heart failure, and death. In fact, all of the plaintiffs have been diagnosed with congestive heart failure or other cardiac symptoms; some of the lawsuits were brought on behalf of saxagliptin users who died, according to The New Jersey Law Journal.
The 14 cases were brought on behalf of plaintiffs nationwide. The first lawsuits that attempted to associate saxagliptin to heart failure were filed in state court in San Francisco, California, in September 2016. The lawsuits were re-filed in New Jersey after a judge granted a motion on February 1, 2017 by Bristol-Myers Squibb and AstraZeneca to sever and dismiss non-California plaintiffs from the case on grounds of forum non conveniens, The New Jersey Law Journal reported. According to Cornell Law, forum non conveniens is a discretionary power that permits courts to dismiss a case in situation s in which another court, or forum, is better suited to hear the case. Dismissal does not stop a plaintiff from re-filing his or her case in the more appropriate forum.
The New Jersey lawsuits similarly allege that the defendants started selling saxagliptin in 2009 without conducting clinical trials to determine if the drug increased the risk of cardiac events in users; this, even though a 2008 FDA bulletin called on the drugs’ developers to demonstrate that their products do not increase cardiac risks, according to The New Jersey Law Journal. The lawsuits allege design defect and seek to recover on grounds of negligence, failure to warn, breach of warranty of merchantability, and breach of express warranty and implied warranty. The plaintiffs also seek to recover for pain and suffering, economic damages, emotional distress, lost wages, and medical expenses. Accrual of applicable statute of limitations should be tolled by the defendants’ fraudulent concealment, the lawsuits contend. Tolling is a legal doctrine in which the period of time set forth in the statute of limitations is paused or delayed. Certain traditional conditions—the plaintiff is a minor, the plaintiff is deemed clinically insane—will toll the statue of limitations. In this case, tolling is suggested due to the fraudulent concealment by the defendants, law plaintiffs’ lawsuits argue.
How Type II Diabetes Drug Work
Onglyza and Kombiglyze XR are used in conjunction with diet and exercise to reduce blood sugar in adults who are diagnosed with Type 2 diabetes. The drugs work by increasing the insulin produced by the body following meals, which is when blood sugar is at its highest.
When people are diagnosed with Type 2 diabetes, they maintain higher sugar, or glucose, blood levels, as the body is unable to make or appropriately metabolize the hormone, insulin. When untreated, Type 2 diabetes may lead to serious and life-threatening health problems.
Incretin mimetics are GLP-1-based diabetes therapies, that are made with natural substances that reduce increased blood sugar levels. The drug treatment is used in patients who have been diagnosed with unusually low insulin levels or in patients whose bodies are unable to efficiently utilize insulin. Incretin mimetics mimic, or imitate, the body’s incretin hormones. These hormones stimulate insulin release following meal consumption.
FDA Calls for Stronger Saxagliptin Labeling
In 2015 an FDA committee recommended the agency require the addition of a heart failure warning on the label for saxagliptin-containing medications after reviewing the drug makers’ internal study revealing a significant increase in the risk of being hospitalized for heart failure. The recommendation was followed in 2016 by an FDA announcement indicated that patients saxagliptin experience an increased risk of heart failure, and requiring a revised warning label on the drug.
Studies Tie Onglyza and Kombiglyze XR to Increased Hospitalization Rate for Heart Failure
The agency requests followed release of a study published in the New England Journal of Medicine (NEJM) that revealed an increased hospitalization rate for heart failure when Onglyza and Kombiglyze XR are used. Heart failure is a cardiac condition under which the heart does not appropriately pump blood.
The drug maker was expected to provide trial data to the agency by early March 2014. At that time, the FDA will conduct a complete review and publicly report its findings. Although the FDA considers the NEJM data preliminary, review of the drug’s clinical trial data is part of a larger review of all Type 2 diabetes drug treatments and cardiovascular risks.
As of a May 2017 report, a recent Brigham and Women’s/Harvard study discovered that patients taking Onglyza were likelier to be hospitalized for heart failure.
Studies Reveal Pancreas Harm Associated with Onglyza and Kombiglyze XR, Other Incretin Mimetics
Studies have long associated Type 2 diabetes medications such as Onglyza and Kombiglyze XR, which are known as “incretin mimetics” to increased risks of developing pancreatitis.
In April 2014, the agency began a safety review of saxagliptin following a clinical trial entitled “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus”(SAVOR) that suggested the drugs were tied to a 27 percent increase in hospitalizations for heart failure and increased risks for all-cause mortality. On April 14, 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 14-to-one recommending new data concerning a potential link between the saxagliptin and heart failure be added to the labels of all saxagliptin-containing drugs.
In 2015, the “Warnings and Precautions” sections of the Onglyza and Kombiglyze XR labels were updated to note a potential tie between the drugs and an increased risk of heart failure, specifically in those patients with a history of heart and kidney disease. Patients taking these drugs are advised to contact their physicians if any of the signs or symptoms of heart failure occur, including:
- Chest pain
- Difficulty breathing when lying down
- Persistent coughing
- Rapid, irregular heartbeat
- Tiredness, weakness, fatigue
- Unusual shortness of breath during daily activities
- Weight gain with swelling in the ankles, feet, legs, stomach
Onglyza and Kombiglyze XR were among a number of drugs recently reviewed in a study that looked at adverse drug reaction reports (ADRs), according to researchers in Italy who confirmed the association between the medications and damage to the pancreas, according to a prior Adverse Events report. Study results were published in the November 13, 2013 issue of Informa Healthcare.
The review involved data from the Italian Spontaneous Adverse Drug Reaction (ADR) Reporting Database that revealed relevant cases of ADRs associated with incretin mimetics. The researchers reviewed 1,169 reports involving incretin mimetics, including Onglyza and Kombiglyze XR. The review included 90 cases of pancreatitis or elevated pancreatic enzyme levels, according to the Adverse Events report and the researchers concluded that the data verified an association between incretin mimetics and pancreatic impairment and recommended that patients taking incretin mimetics, such as Onglyza and Kombiglyze XR, should be monitored for potential pancreas injury.
Another published piece in the journal, BMJ, indicated that incretin mimetics, such as Onglyza and Kombiglyze XR, might be riskier than initially believed. That report also revealed that drug makers of incretin mimetics withheld information on the potentially dangerous effects of this class of drugs.
After reviewing thousands of pages of regulatory documents that were obtained under Freedom of Information rules, BMJ located unpublished data indicating that “unwanted proliferative or inflammatory pancreatic effects,” are associated with use of incretin mimetics.
Another study published March 22, 2013 in the journal, Diabetes, revealed abnormal changes, including pre-cancerous lesions, in the pancreases of eight people who had taken GLP-1-based medications, when compared with patients who took other diabetes medications, according to a prior report by Medscape Medical News.
Thousands of Adverse Event Reports Cite and Onglyza, Kombiglyze XR
Utilizing FDA Adverse Event Reporting System (FAERS) data received from November 1, 1997 to December 31, 2012 and aggregating and standardizing that data by the Adverse Event RxFilter process, researchers discovered 4,512 reports of pancreatitis and 14 cases of elevated pancreatic enzyme levels in which incretin mimetics were indicated as the primary suspect. Of 4,512, the team identified 2,478 hospitalizations and 113 cases in which patients died and incretin mimetics were indicated as the primary suspect.
The FDA issued a “Drug Safety Communication” in March 2013 that indicated that it was “…investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for Type 2 diabetes.”
Legal Help for Victims of Onglyza, Kombiglyze XR Type II Diabetes Medication
If you or someone you know sustained Onglyza- or Kombiglyze XR- heart failure, pancreatitis, other related illnesses, or death following use of these, or other, incretin mimetic medications, you may have valuable legal rights. We urge you to contact our Onglyza and Kombiglyze XR lawyers today by filling out our online form, or calling 1-800-YOURLAWYER (1-800-968-7529) today.
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