A relatively recent addition to the Type 2 diabetes drug market, Onglyza is a popular medication used to control blood sugar. An active DPP-4 (dipeptidyl-peptidase 4) inhibitor, Onglyza assists the pancreas with insulin creation. The drug is popular, in part, because it does not induce the weight gain associated with many other diabetes treatments. Unfortunately, while Onglyza minimizes weight gain, it may significantly increase the risk of heart failure and pancreatic cancer. In some patients, DPP-4 inhibitors such as Onglyza may also lead to severe joint pain.
The Dangers of Onglyza
Approved by the United States Food and Drug Administration (FDA) in 2009, Onglyza (saxagliptin) helps those diagnosed with Type 2 diabetes control their blood sugar. The drugs use by Type 2 diabetics who do not suffer from diabetic ketoacidosis, or increased ketones in the urine or blood. Unlike many diabetes medications, Onglyza does not lead to weight gain. Thus, it is a very popular solution among diabetics who wish to control their blood sugar while also controlling their weight. The drug has skyrocketed in popularity in recent years and could easily exceed sales of $2.47 billion by 2018.
Although Onglyza is a useful tool for controlling blood sugar, its use is accompanied by several risks and adverse side effects, many of which can be deadly. Perhaps the most concerning of these is the increased risk of heart failure, particularly among those already exhibiting cardiovascular problems or liver damage. This risk has been downplayed by drug manufacturer AstraZeneca.
An FDA-reviewed cardiovascular outcomes trial referred to as SAVOR has found that patients prescribed Onglyza are far more likely to experience heart failure than others diagnosed with diabetes. The study found a 27 percent increase in first-time hospitalization rates for those taking Onglyza. Additionally, the study noted a significant increase in all-cause mortality. However, upon reviewing the case, the FDA noted that some patients might have suffered serious medical complications before they passed away.
Not only is Onglyza linked with heart failure, multiple reports indicate that it and other DPP-4 inhibitors may lead to chronic pancreatitis, which, in turn, may result in pancreatic cancer. One particularly compelling study conducted by researchers at UCLA indicates that patients who undergo incretin therapies (such as taking Onglyza) may experience abnormal pancreatic growths.
However, industry-funded trials demonstrate no increased risk of pancreatic cancer. At this point, the link between Onglyza and pancreatic cancer remains unclear, but it’s evident that more research is needed.
Since Onglyza’s release, several patients have suffered heart failure and other cardiovascular events. In some cases, the cardiovascular problems linked to the drug have resulted in death. Those who are lucky enough to survive face large medical bills attached to long hospital visits and ongoing rehabilitative care. The emotional duress associated with Onglyza-induced cardiovascular events can also be severe, both for sufferers and their loved ones. In cases involving wrongful death, the spouses and family members of victims may seek compensation for funeral and burial costs, as well as caregiving costs incurred while the victim was still alive.
In addition to seeking compensatory damages, Onglyza victims are encouraged to seek punitive damages, which can be used to send a message and hold drug manufacturer AstraZeneca accountable. The drugmaker has marketed the diabetes medication as a safe and effective treatment while downplaying the associated risks. Consumers focus more on the possibility of limited weight gain than on the potential dangers of taking this medication. However, many would likely refuse the drug if they were aware just how dangerous it could be.
Victims who seek punitive damages can alert fellow diabetics to the dangers associated with Onglyza, thereby preventing future cardiovascular incidents. If enough harmed individuals speak out, AstraZeneca may finally begin to devote sufficient attention to Onglyza’s risks and side effects — as it should have done all along.
FDA-Based Onglyza Warnings
In 2008, the FDA issued more stringent recommendations for the evaluation of Type 2 diabetes drugs. These recommendations aimed to procure more exhaustive examinations of various medications’ cardiovascular risks — particularly during the development stage. Onglyza technically met the FDA’s 2008 requirements, but the studies conducted on the drug were not deemed sufficient. Clinical trials were considered unreliable, in part, because they only lasted 62 weeks, compared to just over two years for post-marketing drug studies.
In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted almost unanimously to recommend that new safety information regarding the heightened risk of heart failure be highlighted on safety labels for Onglyza. One committee member went even further, suggesting that the drug is withdrawn from the market. More recently, the FDA has recommended that healthcare professionals discontinue the use of Onglyza and other medications that include saxagliptin and alogliptin for diabetes patients who exhibit cardiovascular problems. Although drugs containing alogliptin (such as Nesina) have also been deemed potentially risky, the FDA is most concerned about Onglyza and other drugs featuring saxagliptin.
Rochelle Gibson v AstraZeneca
Onglyza lawsuits have been limited thus far, but as new information regarding the drug’s cardiovascular risk is released, victims and their loved ones are more inclined to speak out via the legal system. One brave woman has stepped forward, and others are expected to join her in speaking out against AstraZeneca and other DPP-4 inhibitor manufacturers.
Grieving daughter Rochelle Gibson filed a lawsuit against AstraZeneca following Lillie Ree Gibson’s 2013 death. Diagnosed with Type 2 diabetes, Gibson’s mother was prescribed Onglyza in 2010. After suffering heart failure for the first time in 2011, she was hospitalized twice before her death. Gibson now seeks damages of over $50,000, as well as punitive damages and coverage of legal costs.
Current Lawsuits on Onglyza
Current lawsuits involving Onglyza remain limited, but several victims have spoken out against similar drugs, including Januvia and Victoza. Plaintiffs in these cases allege that the incretin mimetics — which are very similar to Onglyza — increase the risk of pancreatic cancer.
More information regarding the link between Onglyza and heart failure is needed, but at this point, it is clear that AstraZeneca has failed to conduct the pre-marketing research necessary to ensure that all patients prescribed Onglyza experience minimal cardiovascular and pancreatic risks. Recent FDA recommendations have helped to alert diabetes patients to these risks, but these suggestions may not go far enough. At this point, it is up to injured parties and their loved ones to get the word out. A good lawyer can help you obtain the evidence needed to prove that AstraZeneca did not conduct adequate pre-market trials before releasing Onglyza — and that the drug manufacturer failed to warn diabetes patients of the medication’s associated risks.