AstraZeneca, BMS Face 14 New Onglyza Heart Failure Lawsuits
The type 2 diabetes drug Onglyza (saxagliptin) is the subject of 14 new lawsuits filed against manufacturers AstraZeneca and Bristol-Myers Squibb (BMS). Plaintiffs allege that Onglyza caused heart failure, and that drug makers failed to warn of the risks. An estimated 150 to 200 Onglyza heart failure lawsuits are pending nationwide, legal experts say. The U.S. Food and Drug Administration (FDA) updated the label on Onglyza and other diabetes drugs to include the risk heart failure last year.
Parker Waichman LLP keeps up-to-date with drug and medical device injury litigation news. The firm, which has decades of experience successfully representing clients in drug injury lawsuits, continues to offer free legal consultations. Contact one of our attorneys today if you have any questions about filing an Onglyza heart failure lawsuit.
Onglyza’s main active ingredient in saxagliptin, which is also present in the diabetes drug Kombiglyze XR (saxagliptin and metformin extended release).
According to the New Jersey Law Journal, 14 Onglyza/Kombiglyze XR lawsuits were filed in the District of New Jersey alleging that the drug makers failed to warn about heart failure risks. Suits allege that drug makers failed to warn patients and their physicians about an increased risk of cardiac arrest, congestive heart failure and death.
Initially, the suits were filed in San Francisco in September 2016. The lawsuits were re-filed in New Jersey after a San Francisco judge granted a motion to defendants to sever and dismiss non-Californian plaintiffs on Feb. 1.
The U.S. Food and Drug Administration (FDA) approved saxagliptin to treat type 2 diabetes in 2009. Lawsuits allege that, prior to gaining approval, drug makers failed to adequately assess whether the medication presented a risk of heart failure. Plaintiffs point out that, in 2008, regulators called on makers of diabetes drugs to prove their products do not present heart risks.
AstraZeneca and BMS allegedly knew of the heart failure risk but failed to disclose this information, the suits claim. Plaintiffs allege that they would not have taken Onglyza or Kombiglyze XR if they were fully informed of the risks.
Plaintiffs allege that saxagliptin is defective, and increases the risk of heart failure. Onglyza and Kombiglyze XR users suffered congestive heart failure and other problems, allegedly due to the defective nature of the medication. Some lawsuits are wrongful death claims filed on behalf of people who died after taking the diabetes medication.
The lawsuits allege negligence, failure to warn, breach of warranty of merchantability, and breach of express and implied warranty. Plaintiffs are seeking damages for medical expenses, lost wages, economic damages, pain and suffering, and emotional distress.
Additionally, the plaintiffs argue that any applicable statute of limitations should be tolled (negated) due to the companies’ alleged fraudulent concealment.
FDA Warns of Heart Failure with Onglyza, other Diabetes Drugs
The FDA updated the label on Onglyza and other diabetes medications in April 2016 to warn about the risk of heart failure, especially in patients with existing heart or kidney disease.
The label update applied to any medications containing saxagliptin or alogliptin, which include:
• Onglyza (saxagliptin)
• Kombiglyze XR (saxagliptin and metformin extended release)
• Nesina (alogliptin)
• Kazano (alogliptin and metformin)
• Oseni (alogliptin and pioglitazone)
These medications are dipeptidyl peptidase-4 (DPP-4) inhibitors. Doctors prescribe them to patients to with type 2 diabetes to lower blood sugar, in combination with diet and exercise.
When a patient is diabetic, it means that their body cannot properly use the sugar in their blood for energy. This causes blood sugar levels to rise, leading to various complications. Type 1 diabetes is caused by a lack of insulin, the hormone that tells cells to take up glucose. In patients with type 2 diabetes, the body develops insulin resistance. In this case, the body does make enough insulin but cells stop responding to it.
Heart failure means the heart is not strong enough to pump blood adequately to the rest of the body. The FDA says patients taking DPP-4 inhibitor drugs should seek medical attention immediately if they experience symptoms of heart failure, including:
• Unusual shortness of breath during daily activities
• Trouble breathing when lying down
• Tiredness, weakness, or fatigue
• Weight gain with swelling in the ankles, feet, legs, or stomach
Patients taking diabetes drug should not stop treatment on their own. The FDA says patients should speak with their physician first.
The FDA said its “safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. Heart failure can result in the heart not being able to pump enough blood to meet the body’s needs. As a result, we are adding new warnings to the drug labels about this safety issue.”
The agency announced that it would review heart risks associated with saxagliptin in 2014. Regulators launched the review based on a study published in the New England Journal of Medicine. Findings showed that saxagliptin was associated with a higher rate of hospitalization for heart failure compared to an inactive ingredient.
FDA Panel Says Onglyza Should Carry Heart Failure Warning
In April 2015, the FDA Endocrinologic and Metabolic Drugs Advisory Committee met to discuss the heart risks of diabetes drugs.
The expert panel reviewed data from the SAVOR trial, which contained data from 16,000 patients. Panelists concluded that the Onglyza warning label should be updated to include the risk of heart failure, noting a 27 percent increased risk of heart failure hospitalizations in patients taking saxagliptin compared to placebo.
The FDA also reviewed clinical trial data before updating the warning label.
In each trial, investigators looked at whether saxagliptin- or alogliptin-containing medications increased the risk of being hospitalized for heart failure. In the saxagliptin trial, 3.5 percent of patients taking saxagliptin were hospitalized for heart failure. Comparatively, 2.8 percent of patients taking a placebo were hospitalized for heart failure. Patients with a history of heart failure or kidney problems were particularly at risk.
The risk of heart failure was also higher among patients taking alogliptin compared to those taking a placebo, clinical data from the alogliptin trial showed. Among patients taking alogliptin, 3.9 percent were hospitalized for heart failure compared to 3.3 percent of those taking a placebo.
Filing an Onglyza Heart Failure Lawsuit
If you or someone you know has questions about filing an Onglyza heart failure lawsuit, contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).