Everything You Need to Know About the Dangerous Side-Effects of Onglyza (Saxagliptin)
Onglyza is the brand name for the generic compound, Saxagliptin. Onglyza is a hypoglycemic medication that is used to treat Type 2 diabetes. Subsequent studies found that Onglyza could cause heart failure. Thereafter, in April 2016, the Food and Drug Administration (“FDA”) issued a warning that taking Onglyza could increase the risk of heart failure. A smattering of lawsuits followed against the pharmaceutical manufacturers AstraZeneca and Bristol-Myers Squibb.
This article will go over the science behind Onglyza (Saxagliptin), in particular, what it treats and how. Next, this article will go over the subsequent medical studies and FDA reviews which linked Onglyza to heart failure, the risk it poses, and results from those findings. Finally, this article will conclude with a review of the legal tools that you can use to recover compensation from Bristol-Myers Squibb and AstraZeneca if you or a loved one was injured while using Onglyza.
What is Onglyza (Saxagliptin)?
Onglyza is a hypoglycemic inhibitor medication (anti-diabetes medicine). Onglyza is a DPP-4 inhibitor which slows down the breakdown of incretin hormones. Incretin is a group of hormones that stimulate the production of glucose (i.e. sugar) in the body. The pancreas then releases insulin to slow down the production of glucose. It is the interaction of these two hormonal groups – incretin and insulin – that allows your body to regulate its sugar (i.e. energy).
What Does Onglyza Treat?
Diabetes is the result of your body’s inability to regulate its glucose (sugar) levels. This failure to regulate glucose can arise in a variety of ways including reduced incretin production and immunity to the effects of insulin. Onglyza was invented to treat Type 2 diabetes. There are three types of diabetes:
- Type 1 (i.e. “juvenile diabetes”): develops in children and is traced based on family history. Type 1 diabetes is typified by a failure to produce enough insulin It is not known what precisely causes Type 1 diabetes, all that is known are the effects and how to manage the condition. You probably see younger people with devices on their hips that look like pagers, these are insulin delivery systems that automatically measure the glucose levels and release insulin as needed (think of them like artificial pancreases).
- Type 2 (i.e. “adult-onset diabetes”): develops in adults and is linked to poor diet, lack of exercise, and family history. Type 2 diabetes has the same characteristics of Type 1, however, while people living with Type 1 diabetes do not produce enough insulin, people living with Type 2 develop immunities to insulin which reduces its effectiveness. In essence, your body is becoming immune to insulin, so your body is forced to produce more insulin for the same effect, causing more stress on your pancreas, and further exacerbating the condition.
- Gestational Diabetes: develops in pregnant women who do not have a history of diabetes or high glucose levels. Gestational diabetes is not treated by Onglyza.
Onglyza was developed to treat Type 2 diabetes, i.e. people who have grown immune to the insulin that their bodies naturally produce.
How Does Onglyza work?
Onglyza treats Type 2 diabetes by slowing the breakdown of incretin. Incretin is a hormone that is released by the intestines and is linked with an increase in insulin levels when blood sugar is high and therefore reducing the level of glucose in the body. Onglyza is typically paired with a sulfonylurea (such as glyburide or gliclazide), metformin, and diet and exercise to bring blood sugar levels under control in patients living with Type 2 diabetes.
Possible Side-Effects of Onglyza Known Around the Time it was Marketed
Every medication comes with a list of side-effects, it is an inevitable part of the treatment. No test or doctor can know how every person on the planet will react to the medication (allergies, immunities, etc.) therefore a critical part of any drug development is identifying the side-effects and warning doctors and patients of these effects. Furthermore, the detrimental side-effects, when paired with a different medication or treatment plan, could prove more dangerous than the benefits Onglyza provide. In fact, it is often when companies fail to adequately warn doctors and patients of the side-effects that they run into lawsuits such as the ones surrounding Onglyza.
Some common side-effects of Onglyza include headaches, urinary tract infections, and upper respiratory tract infections. As you read above, Onglyza arrests the breakdown of incretin which increases insulin levels and reduces glucose levels so Onglyza can and does cause low blood sugar in patients. Patients often experience low blood sugar if they are taking Onglyza in conjunction with another diabetes medication. Low blood sugar can express itself through the following symptoms:
- Change in mood and/or vision;
- Rapid heartbeat; and
Onglyza can also cause joint pain that can be mild or severe. It is also known to cause swelling or fluid retention in the peripheries (such as hands, ankles, and feet). The swelling can be exacerbated in people who are also taking a thiazolidinedione. Onglyza has also been known to cause bullous pemphigoid which is a skin reaction that causes blisters.
These side-effects, while serious, are typically not fatal in a lot of people. However, these side-effects are not what is causing AstraZeneca and Bristol-Myers Squibb all their legal troubles, rather, it is the severe or fatal side-effects that were later discovered by subsequent studies.
Fatal Side-Effects of Onglyza
Subsequent medical studies found that Onglyza is linked to two serious conditions (1) heart failure and (2) pancreatitis (i.e. inflammation of the pancreas). Heart failure is a turn-of-phrase that means increased likelihood for heart attacks. The risk is elevated if you have a history of heart failure in your family. Heart failure is a condition which refers to your heart’s inability to pump enough blood to your body either because it can’t pump with adequate force or because it can’t fill with enough blood. It can be linked to shortness of breath, exhaustion, dizziness, irregular heartbeat, swelling in the lower body or stomach, and shortness of breath during normal activities. Heart failure can be a fatal condition resulting in cardiac arrest because the heart stops working.
Pancreatitis can range from benign or mild to possibly fatal. Everyone’s pancreas becomes inflamed at some point, whenever it needs to work overtime to balance out whatever someone has eaten. However, some inflammation can be severe and require hospitalization or even lead to death.
- Heart Failure
A series of studies which concluded in 2013, found that Onglyza was not linked to heart attacks. However, the studies did find a link between taking Onglyza and increased hospitalization for heart failure. A study sponsored by the Brigham and Women’s Hospital in Boston examined 16,492 patients and found an additional 0.7 percent of patients taking Onglyza were hospitalized for heart failure over those who were taking the placebo. To put that in perspective, if 1,000 patients took Onglyza an additional seven patients would be hospitalized for heart failure. If you consider 10,000 patients, that becomes 70 more people. Now, consider that Onglyza has been sold to millions of patients all over the world and now you are talking about tens of thousands of additional cases of heart failure and that many more related deaths.
Based upon these findings, the FDA conducted a safety review which concluded in 2016. The safety review found Onglyza (Saxagliptin) can result in an increase of heart failure in patients. The FDA emphasized the risk was particularly acute in people who have a history of heart or kidney failure. The FDA then imposed new warnings on Onglyza.
The FDA recommends that physicians halt prescribing Onglyza if their patients report the following symptoms:
- Weight gain (you’re not supposed to gain weigh on this drug);
- Swelling in the hands, ankles, or feet;
- Trouble breathing when lying down (because your heart no longer has the benefit of gravity to help it move blood);
- Shortness of breath during light activities; or
- Fatigue, tiredness, or weakness.
Several studies also found small but significant upticks in rates of pancreatitis in patients who took Onglyza compared to those who took the placebo. A series of studies were conducted after the FDA issued its warning about the risk for Janumet and Januvia (sitagliptin). Specifically, three major studies were conducted: (1) SAVOR-TIMI 53; (2) TECOS; and (3) EXAMINE. These studies fund that there was a small but measurable increase in acute pancreatitis in patients who took Onglyza.
There are two types of acute pancreatitis: mild and severe. Mild pancreatitis is inflammation of the pancreas and is usually resolved after a few days in the hospital, not eating, and a steady diet of intravenous fluids. Mild pancreatitis might express itself as pain in the abdomen or back. Severe acute pancreatitis is concerning because can it can result in organ failure, infected necrosis, necrosis, abscess, and pseudocyst. The body also experiences a substantial drop in fluids as the body works in overtime to repair the pancreas before it shuts down, the result is that you can go through hypovolemic shock which can be life-threatening because the body is starved of oxygen-rich blood. Based on these studies, the FDA also warned in the same announcement that treating physicians should monitor possible symptoms indicating pancreatitis, especially if Onglyza is paired with other diabetes medications such as metformin.
Have Lawsuits Been Filed?
Yes, hundreds have been filed. The first lawsuit was a wrongful death action filed in Cook County, Illinois. Now, hundreds of lawsuits have been filed all over the country for a variety of reasons, mostly involving wrongful death and failure to warn (more on that later) adequately.
Moreover, many more suits have been filed in California over Onglyza’s link to pancreatitis. Those suits have been consolidated into a multijurisdictional lawsuit in the federal district court in San Diego, California. The Southern District Court has jurisdiction for purposes of discovery and pre-trial motions but individual plaintiffs must file and win their individual cases. The consolidation allows merely plaintiffs to overcome procedural hurdles and prove (1) that they took the drug and (2) suffered harm – assuming that the primary plaintiffs’ counsel in San Diego is successful in linking Onglyza, as well as other drugs, to pancreatic cancer and pancreatitis.
So, if you suffered from pancreatic cancer or pancreatitis while taking Onglyza, your case might be one of the cases consolidated in San Diego, California. However, if you or a loved one suffered from heart failure, then your case will proceed on a different path.
How to Recover Compensation if You or a Loved One was Harmed by Onglyza
The most common fatal side-effect of Onglyza was heart failure which is often fatal. The result is hundreds of lawsuits filed from California to New York alleging that AstraZeneca and Bristol-Myers Squibb are responsible for the wrongful deaths of patients form heart failure who were taking their drugs. There are two main ways you can recover for being harmed by Onglyza (or any prescription drug): (1) wrongful death and (2) product liability.
- Wrongful Death
In the typical lawsuit, you are injured and you bring a lawsuit to seek compensation for your injury – to “make you whole.” At least, that is the theory of money damages. However, how do you recover compensation if you are killed as a result of another’s actions? You’re dead, so you can’t file a lawsuit in your name to seek compensation. To remedy these situations, the law created a new class of lawsuits – wrongful death.
Wrongful death actions may be filed by the surviving members of a person’s family who is killed due to the negligent or intentional acts of another person (or legal entity). There are three key issues to a wrongful death action:
- Who can bring the action?
- The burden of proof
- What can be recovered?
First, who can file a wrongful death action? Only the personal representative of the decedent (the person who passed away) may file the lawsuit. Every state has a wrongful death statute which prescribes who the personal representative is. The personal representative can be a trustee, executor of an estate, a surviving spouse, children, etc. However, the person must be a personal representative in order to bring the suit.
- Wrongful Death Elements
To prevail on a wrongful death action, you must prove the following elements: (1) that a person died; (2) whose death was caused by the negligent or intentional acts of another person; (3) there are family members who suffered monetary injury due to the death; and (4) that the person bringing the suit is the personal representative.
The first element is easily met in 99 percent of cases, you need to produce proof the individual is dead. The second element is more complicated (and is the hardest fight at trial). The second element requires you to link the death of your loved one to the actions of the defendant. In some cases, it is simple, such as a car accident. However, proving that AstraZeneca or Bristol-Myers Squibb caused your loved one’s heart failure due to Onglyza is harder to establish. Without getting too much into the weeds of litigation strategy, you will need to prove some basic facts:
- Your loved one was prescribed Onglyza;
- Onglyza causes heart failure;
- Your loved one died from heart failure;
- Nothing else adequately explains your loved one’s death by heart failure.
Some of these elements are easy to prove such as taking Onglyza and cause of death for your loved one. However, for every study you submit to the court, the defense can likely produce their own showing no statistically significant link between Onglyza and heart failure. Furthermore, as stated above, medicine is a complicated business and there are numerous side-effects that cannot all be anticipated. The defense could argue that your loved one suffered heart failure due to other issues, such as family history or a different medication. Once the second element is established, you need to prove damages (i.e. the third element).
Damages refer to measurable, economic harm for which you can be handed money as a way to compensate you for the loss. Yes, in reality, everyone knows that no pile of money can replace a loved one. However, the U.S. legal system was built on the premise that loss can be reduced to a specific dollar amount which provides perfunctory compensation. There are several types of damages that you can establish — first, economic (or pecuniary) losses.
Economic losses refer to things that can be measured with pay stubs, receipts, or bills. For example, you can recover the cost of your loved one’s medical care (doctors, ambulance ride, medication, and procedures). You can also recover for lost anticipated wages. In this case, you would consult with an expert witness who would (1) review your loved one’s current career and (2) project based on actuarial tables, how much longer she would’ve worked and (3) extrapolate from that an estimated total of lost wages.
Next, you can recover non-economic losses. These refer to a range of damages but the most familiar is pain and suffering. Pain and suffering refer to the pain caused by the defendant’s actions and the suffering the decedent endured prior to death. Pain and suffering is generally established by firsthand witness testimony (i.e. the victim telling his story of the assault). But, in this case, you often must rely on third-party witnesses to establish your loved one’s pain and suffering. Furthermore, these damages are often reduced or insignificant (i.e. not worth pursuing) because the duration of the suffering wouldn’t have been long compared to someone who spends years recovering in physical therapy.
Finally, depending on the defendant’s actions, you can recover punitive damages. Punitive damages are imposed because the defendant acted with reckless or intentional conduct which caused the wrongful death. In the case of Onglyza, if it is found that either AstraZeneca or Bristol-Myers Squibb knew about the increased risk of heart failure and deliberately chose to market the medication without a warning or informing the FDA, then they could be subject to punitive damages. Punitive damages are imposed to deter future bad conduct and are often a multiplier of economic damages. Punitive damages can be as low as 3x economic damages and up to 10x (but judgments that high are often reduced on appeal).
Product Liability – Onglyza
Finally, if you suffered from heart failure but didn’t pass away, you can still recover damages under product liability. Product liability is a legal theory that imposes the burden of proof on the manufacturer, seller, and distributor of a product. Ordinarily, it would help if you proved that the product was dangerous due to the defendant’s negligence and caused your harm. However, in product liability cases, you simply need to prove you purchased the product, used it in the prescribed manner, and suffered harm – i.e. you don’t need to prove the defendant was negligent.
Pharmaceutical companies are immune to most types of product liability claims because their medications are unavoidably dangerous (unavoidably dangerous products can’t be subject to product liability claims if there is an adequate warning). However, many pharmaceutical companies run afoul of warnings because they do not list every possible side-effect of the medication. You probably noticed that the FDA didn't require AstraZeneca or Bristol-Myers Squibb to post a warning. However, this obligation exists independent of regulatory oversight, meaning, companies can't rely on government error to excuse their neglect. Pharmaceutical companies are in a better position than the government or patients to discover the potential side-effects of their medications. In this case, AstraZeneca and Bristol-Myers Squibb omitted warnings on Onglyza about the risk of heart failure and pancreatitis in their initial marketing to patients and doctors. That oversight, whether intentional or not, could subject AstraZeneca and Bristol-Myers Squibb to millions of dollars in lawsuits.
Help Finding an Onglyza (Saxagliptin) Lawsuit Near Me
If you need help finding a professional to assist you with a potential Onglyza (Saxagliptin) lawsuit near you, contact Consumer Alert Now at (800) 511-0747 for assistance. Consumer Alert Now informs all of its clients of ongoing, major lawsuits involving medications, treatments and other complex multi-jurisdiction litigation matters. Consumer Alert Now can tell you everything you need to know about the dangerous side-effects of Onglyza and what to do if you suffered harm anywhere in the United States.