Onglyza (Saxagliptin) Makers Sued over Alleged Heart Failure Risks

Lillian ChiuDefective Drugs

Onglyza Makers Sued over Alleged Heart Failure Risks

New Onglyza Lawsuits Allege AstraZeneca, BMS Failed to Warn

AstraZeneca and Bristol-Myers Squibb (BMS) are facing at least 14 new lawsuits alleging that the companies failed to warn about the risk of heart failure with the type 2 diabetes drug Onglyza (saxagliptin). Last year, the U.S. Food and Drug Administration (FDA) updated the label on Onglyza and other diabetes medications to warn about the risk of heart failure, particularly in patients with a history of heart or kidney disease. Onglyza makers are facing roughly 150 to 200 Onglyza heart failure lawsuits nationwide, legal experts say.

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.

The generic name for Onglyza is saxagliptin. Saxagliptin is also an active ingredient in the diabetes drug Kombiglyze XR (saxagliptin and metformin extended release).

In September, Onglyza heart failure lawsuits were filed in San Francisco. However, on Feb. 1, a San Francisco judge granted a motion to defendants to sever and dismiss non-Californian plaintiffs. As a result, 14 Onglyza lawsuits were re-filed in the District of New Jersey, according to the New Jersey Law Journal. The suits are filed on behalf of Onglyza and Kombiglyze XR users who suffered cardiac arrest and congestive heart failure. Some are wrongful death cases filed on behalf of patients who died. Plaintiffs allege that AstraZeneca and Bristol-Myers Squibb knew about the risk of heart failure but failed to warn users or the medical community. The lawsuits allege that plaintiffs would not have taken Onglyza if they were aware of the risks.

Onglyza and Kombiglyze XR plaintiffs also allege that manufacturers failed to properly test saxagliptin for heart failure before the drug hit the market. The FDA approved saxagliptin in 2009 to treat type 2 diabetes. When drug makers seek approval for a new medication, they must show that the drug is safe and effective for its intended use. Plaintiffs note that the FDA asked makers of diabetes drugs to prove their products do not present heart risks in 2008. Onglyza lawsuits allege that the diabetes drug is defective, presenting a risk of heart failure in users.
AstraZeneca and BMS are accused of negligence, failure to warn, breach of warranty of merchantability, and breach of express and implied warranty. Lawsuits are seeking damages for medical expenses, lost wages, economic damages, pain and suffering, and emotional distress.

The plaintiffs also assert that any applicable statute of limitations should be tolled (negated) due to the companies’ alleged fraudulent concealment.

Onglyza Label Updated to Include Heart Failure Risk

Last April, the FDA announced that the label on Onglyza and other diabetes medications would be updated to include the risk of heart failure. Regulators warned that, based on clinical data, patients with existing heart or kidney disease are particularly at risk.

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)

The drug affected by the label update are a class of diabetes medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors. They are prescribed to patients with type 2 diabetes to lower blood sugar, in combination with diet and exercise.

Patients with diabetes have high blood sugar because the body cannot break down glucose (the simplest form of sugar) properly for energy. With type 1 diabetes, this is because the body does not produce enough insulin, the hormone signaling cells to take up glucose. In patients with type 2 diabetes, the body has enough insulin but it stops responding to it properly.

According to the FDA, DPP-4 inhibitor drugs may increase the risk of heart failure in some patients, especially if they already have heart or kidney disease. When a patient suffers from heart failure, it means the heart is not pumping blood well enough for the blood to reach 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

The FDA says patients taking diabetes drugs should not stop taking medication without speaking to their physician first.

Regulators said their “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 FDA announced its saxagliptin heart failure safety review in 2014. The review was prompted by a study published in the New England Journal of Medicine showing that saxagliptin was associated with a higher rate of hospitalization for heart failure compared to an inactive ingredient.

FDA Panel Reviews Clinical Data, Advises Heart Failure Warning for Saxagliptin

Prior to the label update, the FDA Endocrinologic and Metabolic Drugs Advisory Committee met in April 2015 to discuss concerns about heart failure with the diabetes drugs.

The panel, comprised of medical experts, reviewed data from the SAVOR trial. The study involved 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 prior to the label update.

Onglyza Makers Sued over Alleged Heart Failure Risks

Onglyza Makers Sued over Alleged Heart Failure Risks

In each trial, researchers studied 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 compared to 2.8 percent of patients taking a placebo. The risk was higher in patients with a history of heart failure or kidney problems.

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).