Onglyza and Heart Failure: Side Effects, SAVOR Findings, and Lawsuit Status
Swollen ankles, a few pounds that showed up in a week, and a new need to sleep propped up on pillows are easy to blame on age or a long summer. For someone with type 2 diabetes taking Onglyza, they are also the warning signs the FDA added to the drug’s label in 2016 after a major trial found more heart failure hospitalizations in patients taking it. This post covers what Onglyza is, what the heart failure evidence shows, what happened to the lawsuits, and when a claim may still exist. When a doctor misses those warning signs, a medical malpractice lawyer at Boesen Law can review whether the care you received met the standard it should have.
What Is Onglyza?
Onglyza is the brand name for saxagliptin, a once-daily tablet for adults with type 2 diabetes. A few basics explain where the heart failure concern came from.
What It Treats
The FDA approved Onglyza on July 31, 2009, as an add-on to diet and exercise to lower blood sugar. Doctors often prescribed it alongside metformin, and a combination tablet, Kombiglyze XR (saxagliptin plus extended-release metformin), followed in November 2010. It is not meant for type 1 diabetes.
How It Works
Saxagliptin belongs to a class called DPP-4 inhibitors. It slows the breakdown of gut hormones called incretins, which prompt the pancreas to release more insulin after meals and less glucagon, the hormone that tells the liver to release sugar. Other drugs in the same class include sitagliptin (Januvia), linagliptin (Tradjenta), and alogliptin (Nesina).
Who Makes It Now
The applications for both brands are now held by AstraZeneca, and FDA records list brand Onglyza as discontinued, with a note that it was not withdrawn for safety or effectiveness reasons. Generic saxagliptin, approved in July 2023, is still sold by prescription.
If you took either brand for years, your pharmacy records are the starting point for any review Boesen Law does.
For answers to your questions, call:
(303) 999-9999
The Heart Failure Signal: SAVOR-TIMI 53 and the FDA Warnings
The concern did not come from lawsuits. It came from a safety trial the FDA required of new diabetes drugs to rule out heart risk.
What the SAVOR Trial Found
SAVOR-TIMI 53 enrolled 16,492 people with type 2 diabetes who either had heart and blood vessel disease or multiple risk factors for it, and followed them for a median of about two years. The drug did not raise the rate of heart attacks or strokes. But 3.5 percent of patients on saxagliptin were hospitalized for heart failure, compared with 2.8 percent on placebo, a 27 percent relative increase that was statistically significant.
What the FDA Did
The agency first flagged the trial in February 2014. On April 5, 2016, it announced that it was adding heart failure warnings to the labels of saxagliptin and alogliptin medicines. A separate trial of alogliptin, called EXAMINE, had shown a similar pattern, 3.9 percent versus 3.3 percent.
Who Faced the Highest Risk
In the trials, people who already had heart failure or kidney problems were the most likely to be hospitalized. The current label tells doctors to weigh the risks before starting Onglyza in anyone at higher risk for heart failure, watch for symptoms during treatment, and consider stopping the drug if heart failure develops.
That last instruction is where a Boesen Law review often focuses: whether your doctor followed it.
Onglyza Side Effects
Heart failure is the headline risk, but the current Onglyza label lists several others worth knowing:
- Common reactions. Upper respiratory infections, urinary tract infections, and headache were the most frequently reported.
- Heart failure. Hospitalization for heart failure was more common than on placebo in the SAVOR trial.
- Pancreatitis. There have been reports of acute pancreatitis, and the label says to stop the drug promptly if it is suspected. Persistent, severe stomach pain that may reach the back is the classic sign.
- Low blood sugar. The risk rises when Onglyza is combined with insulin or sulfonylureas, and doctors may need to lower those doses.
- Serious allergic reactions. Anaphylaxis, swelling of the face or throat, and peeling skin reactions have been reported after approval.
- Severe joint pain. DPP-4 inhibitors can cause severe, disabling joint pain that may start days or years into treatment.
- Bullous pemphigoid. Large, fluid-filled blisters have sent some patients on DPP-4 drugs to the hospital.
- Swelling with certain drugs. Swelling in the legs and feet was more common when Onglyza was taken with a thiazolidinedione such as pioglitazone.
Several of these can be mistaken for something else, which is why the medical record of what you reported, and when, matters so much to a later claim.
What to Do If You Notice Heart Failure Symptoms
The FDA’s 2016 communication listed the signs patients should report. If you take saxagliptin or alogliptin and notice any of them, act in this order:
- Call your doctor right away. Report unusual shortness of breath during daily activities, trouble breathing when lying down, tiredness or weakness, or weight gain with swelling in the ankles, feet, legs, or stomach.
- Call 911 for an emergency. Chest pain, severe breathlessness, or fainting should not wait for an appointment.
- Do not stop the medication on your own. The FDA’s advice is to keep taking it until you talk to your prescriber, because uncontrolled blood sugar carries its own risks.
- Write down dates. Note when symptoms started, what you told your doctor, and what changed in your prescriptions.
- Keep your records. Save pharmacy printouts, pill bottles, and discharge papers from any hospital stay.
Those records support any claim that follows, whether it is framed as a defective drug claim against a manufacturer or a question about the care you received. Boesen Law can gather what is missing if you are too sick to do it yourself.
What Happened to the Onglyza Lawsuits
Many websites still describe Onglyza lawsuits as if they were active. They are not, at least not as a group. Here is the record.
The Federal MDL
In February 2018, the Judicial Panel on Multidistrict Litigation centralized the Onglyza and Kombiglyze XR cases as MDL No. 2809 in the Eastern District of Kentucky, then covering 84 lawsuits alleging heart failure and related injuries. The trial judge later excluded the plaintiffs’ only general causation expert, a cardiologist who relied heavily on the SAVOR results, and entered summary judgment for the manufacturers. On February 13, 2024, the Sixth Circuit affirmed every part of that ruling.
The California Cases
A smaller group of cases was coordinated in California state court. The same expert was excluded there, the manufacturers won summary judgment, and on April 19, 2023, the California Court of Appeal affirmed the judgment.
What That Means for You
Both courts found that one trial showing more hospitalizations was not enough, on its own, to prove that saxagliptin causes heart failure. A new claim against the manufacturer would face those rulings head on. That does not close every door: a claim against a doctor who kept a high-risk patient on the drug despite clear symptoms is a separate question, judged by the standard of care rather than by the drug company’s science. Boesen Law can tell you which of those, if either, fits your facts.
Joseph J. Fraser, III on Living With Heart Failure
Joseph J. Fraser, III, a Boesen Law attorney whose workers’ compensation and SSDI practice has put him on both sides of disability claims, offers this view:
“When a client with diabetes tells me about heart failure, my first question is not who to sue. It is whether they can still work. Heart failure changes what a person can lift, how far they can walk, and how many hours they can stay on their feet, and that has to be documented in a way a disability examiner or an insurer will accept. I have seen these claims from the other side, so I know the records that get benefits approved are the ones that tie each symptom to a specific limitation. If there is also a case against a doctor, those same records help it too.”
If heart failure has taken you out of work, Social Security disability in Colorado may be part of your recovery, and our lawyers handle those claims alongside injury cases.
What Cases Like Yours Have Recovered
Hospitals and physicians defend these cases hard, and Boesen Law has taken them on and won. In one birth injury case, negligent doctors caused a baby lifelong, permanent disability and seriously injured the mother, and the firm secured a joint settlement of $14,800,000. The facts are different from a medication case, but the result shows the firm will go up against medical defendants. More outcomes are listed among our case results.
Send us your records, and an attorney will tell you plainly what they show.
Speak With Boesen Law About Onglyza or a Medical Care Question
A diagnosis of heart failure changes your work, your finances, and your plans, and you deserve a clear answer about whether anyone else is responsible. Boesen Law has recovered hundreds of millions for injured Coloradans, and we will review your prescription history and medical care before recommending anything.
Nothing is owed up front, and there is no attorney fee unless we recover compensation for you. Our team is reachable around the clock, and you can contact Boesen Law today to set up a free, in-person consultation.
FAQs About Onglyza Heart Failure Lawsuits
Has Onglyza been discontinued?
The brand-name tablets have been. FDA records list both Onglyza and Kombiglyze XR as discontinued, and the agency has determined that Onglyza was not pulled for safety or effectiveness reasons. Generic saxagliptin and saxagliptin with metformin have been approved since 2023 and are still prescribed, carrying the same heart failure warning.
Is there still an Onglyza lawsuit I can join?
Not in the sense of an open mass case. The federal MDL and the California coordinated cases both ended in rulings for the manufacturers that were upheld on appeal. Individual claims, especially ones about how a doctor managed a patient’s heart failure risk, are evaluated on their own facts.
What are the most serious Onglyza side effects?
Heart failure, pancreatitis, severe allergic reactions, low blood sugar when combined with insulin or sulfonylureas, disabling joint pain, and a blistering skin condition called bullous pemphigoid are the serious risks on the label. Upper respiratory infections, urinary tract infections, and headache are the most common everyday effects.
How long do I have to bring a claim in Colorado?
It depends on who the claim is against. Under C.R.S. § 13-80-102.5, a medical malpractice case generally must be filed within two years of when you knew or should have known about the injury and its cause, and no more than three years after the act or omission, with limited exceptions. Claims against a drug manufacturer have their own two-year limit. The time limits on personal injury cases are strict, so it is worth checking your dates early.
Call (303) 999-9999 or complete a Free Case Evaluation form
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