Updated May 10, 2018
If you or a loved one developed congestive heart failure while taking Onglyza or Kombiglyze (both of which have the active ingredient saxagliptin), contact our product liability lawyers for a free and confidential consultation by filling out the online form below, by calling my office directly at (215) 948-2718. Or, you can email me at email@example.com.
I’ve written a lot about drug injury lawsuits over the past few years, and I recently spoke on Capitol Hill about the future of prescription drug litigation. You can see the debate here. I have been appointed by multiple federal courts to represent people injured by prescription medications. You can read more about me here.
This website answers frequently asked questions about the link between saxagliptin and heart failure, including:
- Does Onglyza cause heart failure?
- Who might have a claim for compensation? Have there been any settlements?
- Has there been a recall of Onglyza or Kombiglyze?
- What scientific studies have been done to determine the safety of Onglyza and Kombiglyze?
- Is there a class action lawsuit against AstraZeneca, the drug company behind Onglyza and Kombiglyze?
Does Onglyza cause heart failure?
In diabetic patients, the pancreas doesn’t produce enough insulin. Although many processes are involved in the production of insulin, one of the most important processes involves incretin hormones stimulating the pancreas to produce more insulin. Saxagliptin, which is marketed as Onglyza and Kombiglyze XR, is a treatment for diabetes that works by inhibiting dipeptidyl peptidase-4 (DPP-4), an enzyme which breaks down incretin hormones. With more incretin hormones in the body (particularly the incretin “GLP-1”), the pancreas will produce more insulin.
The problem is, DPP-4s aren’t just involved in the production of insulin. For example, back in 2009, researchers warned that “the effects of DPP4 inhibition on the immune system have not been extensively investigated.” In 2012, a separate group of researchers noted that “there is limited information on the cardiovascular actions of these agents in patients with diabetes and established cardiovascular disease,” and pointed out that incretin hormones were extensively involved in processes in the myocardium and in the vasculature of the heart, arteries, and veins. Indeed, research all the way back in 1994 showed that administering the incretin hormone GLP-1 to animals produces quick changes in heart rate and in blood pressure.
In October 2013, AstraZeneca published the results of its clinical trial of saxagliptin, called the SAVOR trial, as in, “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus.” As the authors of the study said, Onglyza use “increased the risk of hospitalization for heart failure.” In February 2014, the FDA issued a Drug Safety Communication, noting that it had “requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure.” In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee produced a thorough report on Onglyza and Kombiglyze XR which concluded “an increased risk of hospitalization for heart failure was noted in subjects treated with saxagliptin, and FDA sensitivity analyses suggested a potential increased risk of all-cause mortality in saxagliptin-treated subjects,” and that there was “a public health implication of this finding.”
Finally, in April 2016, after extensive action by the FDA, the Prescribing Information for Onglyza was revised to include a warning about “heart failure.” Doctors were finally warned to “[c]onsider 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.”
Who might have a claim for compensation? Have there been any settlements?
In most lawsuits over prescription drug injuries, the key issue is whether the drug company should have warned, but did not warn, about a complication or side effect. Neither Onglyza nor Kombiglyze XR has ever warned about a connection between their drugs and:
- Cardiac failure
- Congestive heart failure
- Cardiac arrest
- Myocardial infarction (heart attack)
- Cardiac disorder
- Angina pectoris
- Cardiac flutter
What all of these conditions have in common is that they can be caused by heart failure, which is when the heart weakens and can’t pump blood hard enough to supply the body with enough oxygen or nutrients. We are currently investigating and pursuing cases in which patients who were taking Onglyza or Kimbiglyze XR had a weakening of the heart that required a visit to a doctor, an emergency room, or hospitalization. For more about the signs and symptoms of heart failure, see this page from the American Heart Association, or this page from the Mayo Clinic. Surprisingly, many medical doctors aren’t aware of the link between Onglyza, Kombiglyze, and congestive heart failure. For example, the Mayo Clinic’s page lists medications that have been linked with heart failure, but it doesn’t include diabetes drugs with saxagliptin:
Some medications may lead to heart failure or heart problems. Medications that may increase the risk of heart problems include nonsteroidal anti-inflammatory drugs (NSAIDs); certain anesthesia medications; some anti-arrhythmic medications; certain medications used to treat high blood pressure, cancer, blood conditions, neurological conditions, psychiatric conditions, lung conditions, urological conditions, inflammatory conditions and infections; and other prescription and over-the-counter medications.
We believe that AstraZeneca, which makes Onglyza, has not done enough to inform the medical community about the risks of heart failure, such as by publishing articles in medical journals or by sending out “Dear Doctor” letters.
Even if a patient had signs or symptoms of congestive heart failure before taking Onglyza or Kombiglyze, they might still qualify for a lawsuit and compensation. One of the most interesting aspects of the SAVOR trial is that the clinical trial was designed to account for real-world usage of diabetes drugs. In the trial, more than 80% of patients had pre-existing hypertension, 38% had a prior myocardial infarction, and 12.8% had pre-existing heart failure. Even with those pre-existing conditions accounted for, Onglyza still ended up causing a statistically significant increase in the risk of hospitalization. Thus, even if a patient had heart problems before taking Onglyza, they might still qualify for a lawsuit, because taking the drug increased their risk of injury.
So far, there have not been any Onglyza lawsuit settlements. That is not unusual, because the litigation is in its early stages. See below for more information about the current status of the lawsuits.
Has there been a recall of Onglyza or Kombiglyze?
At present, no, and a recall is unlikely in the foreseeable future. Acute cardiac disorders like heart failure are a very serious and potentially fatal matter, but recalls are unusual. Although Vioxx was withdrawn from sales for similar cardiovascular concerns (for Vioxx, it was heart attack and stroke), in most circumstances, if a prescription medication is shown to contribute towards a serious side effect, the biggest change is typically the addition of a warning. In some instances, a “black box” warning is added to the top of the prescription information provided with the drug.
What scientific studies have been done to determine the safety of Onglyza and Kombiglyze?
As described above, the clearest study on saxagliptin specifically is the “SAVOR” trial that was sponsored by AstraZeneca, which manufactures Onglyza and Kombiglyze.(4) The clinical trial found an increased risk of hospitalization for heart failure. Studies of other DDP-4 inhibitor drugs, like Januvia (sitagliptin), have found an association with hospitalization for heart failure. A study published in 2014 in the Journal of the American College of Cardiology: Heart Failure found that, for patients with a prior diagnosis of heart failure, the use of sitagliptin increased the chance of a patient being hospitalized for heart failure from somewhere between 16% and 192%. As other authors in that same journal issue noted, “the present findings are important and do add to a small but growing body of evidence that suggests DPP-4 inhibitors as a class of drugs, and possibly diabetes drugs in general, may increase the risk of heart failure.”
Although drug companies routinely perform a variety of animal studies before marketing a drug, and sometimes after, the results of those studies are not public. Similarly, drug companies generally do not publicize the results of all of their clinical trials. Medical researchers have, however, tried to understand how DPP-IV inhibitor drugs like saxagliptin can increase the risk of heart failure. One such theory, discussed in this 2018 article, is that the drugs aggravate cardiac fibrosis. Another theory, discussed here, is that these drugs stimulate cardiomyocyte apoptosis, or, in other words, the death of heart muscle cells. The truth is that DPP-IV inhibits have a wide variety of effects in the body, so the underlying mechanism could be several factors acting in combination.
Is there a class action lawsuit against AstraZeneca, the drug company behind Onglyza and Kombiglyze?
Generally, drug injury lawsuits are not filed as “class actions,” where a handful of plaintiffs represent all of the plaintiffs. Instead, drug injury lawsuits are filed individually. In January 2018, the United States Judicial Panel on Multidistrict Litigation ordered “consolidation” of all the Onglyza and Kombiglyze lawsuits in the United States District Court for the Eastern District of Kentucky. As of May 2018, there are approximately 100 lawsuits in that “consolidated” litigation, known as MDL 2809. There are also other lawsuits pending in California state court.
For a free, confidential review of your claim, use the contact form below or call my office directly at (215) 948-2718.