Onglyza and Kombiglyze XR Lawsuits
Nearly 30 million Americans have Type 2 diabetes, a condition that carries life-altering ramifications if not properly controlled. Pharmaceutical companies have cashed in on this growing epidemic with the introduction of several new diabetes drugs, such as AstraZeneca’s Onglyza and Kombiglyze XR.
Along with GLP-1 class treatments like Byetta, DPP-4 inhibitors like Onglyza and Kombiglyze XR have sparked safety concerns in regards to potential health complications like heart failure, pancreatitis, pancreatic cancer and thyroid cancer..
Onglyza & Kombiglyze XR heart risks
In fact, patients who take Onglyza (saxagliptin) to control their blood glucose levels are at a greater risk of being hospitalized for heart failure, according to the FDA. Health regulators recently analyzed the preliminary findings of the SAVOR clinical trial to better determine cardiovascular risks associated with saxagliptin. Beyond a 27 percent increase in heart failure risk, FDA officials also acknowledged a rise in the rate of “all-cause mortality” among study participants who took Onglyza or Kombiglyze XR.
The Sanders Firm is nationally renowned in the arena of pharmaceutical litigation. Our veteran product liability lawyers are currently reviewing Onglyza and Kombiglyze XR lawsuits with patients who suspect their health concerns are linked to a defective or inherently dangerous diabetes drug. The law affords legal remedies for individuals who have been injured by a product that was sold with insufficient warnings or was not properly tested prior to launch. Drug manufacturers may be held liable for damages in the event patients experienced side effects such as heart failure, cardiovascular problems or the development of cancerous tumors after using Onglyza as instructed.
Onglyza and Kombiglyze XR receive FDA approval
Onglyza was approved for sale in the United States in 2009, and quickly garnered massive earnings for drug maker AstraZeneca. Some analysts predict that Onglyza sales may top $2 billion by 2018. Saxagliptin, similar to diabetes drug Januvia, is a type of incretin mimetic. The medication works by increasing the body’s incretins that in turn increase the release of insulin after meals. This action helps lower blood sugar spikes that typically occur after meals.
One year after Onglyza hit the market, the FDA approved Kombiglyze XR, an extended-release pill that Onglyza with Metformin that offered “strong glycemic control across glycosylated hemoglobin levels (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG).” The drug was not indicated for type 1 diabetes patients or those at risk for diabetic ketoacidosis, and has not been studied in patients who are on insulin. Like Metformin, Kombiglyze XR contains a boxed warning for lactic acidosis, a rare but serious metabolic complication that causes side effects like fatigue, muscle pain and difficulty breathing that could result in death.
Despite FDA approval of these two drugs, many questions about side effects and conflicting studies remain unanswered.
Side effects of Onglyza & Kombiglyze XR
Some of the most common side effects of Onglyza and Kombiglyze XR include:
- Urinary tract infections
- Upper respiratory tract infections
- Swelling or fluid retention
The following are more severe side effects linked to saxagliptin:
- Pancreatitis (swelling of the pancreas)
- Severe and persistent joint pain
- Difficulty swallowing or breathing
- Development of pre-cancerous cells
- Pancreatic abnormalities
- Increased risk for heart failure
Heart failure, also called congestive heart failure, is characterized by extreme fatigue, irregular heart rate, confusion and shortness of breath caused by a weakened heart muscle that is unable to sufficiently pump blood throughout the body. Depending on the extent of the damaged heart muscle, treatment may entail lifestyle changes, prescription medications, ventricular assist devices and surgery.
After reviewing the SAVOR clinical data, which included the cardiovascular outcomes of more than 16,000 diabetic patients taking either a placebo or Onglyza, an FDA advisory panel recommended that that AstraZeneca include a warning regarding heart failure risks on Onglyza and Kombiglyze XR labels. One FDA panel member even recommended pulling Onglyza off the market entirely, though this measure was never implemented.
Incretin mimetics and cancer risks
The FDA continues to explore the health risks of incretin mimetic drugs such as Onglyza, which researchers have also linked to pancreatic abnormalities, inflammation and the development of pre-cancerous cells in Type 2 diabetics. In 2013, the medical journal Diabetes published a study in which researchers identified precancerous cellular changes in the pancreatic tissue of patients who had taken mimetic drugs to manage their Type 2 diabetes.
The results weren’t sufficient to demonstrate a definitive link between Onglyza and pancreatic cancer, but U.S. health regulators did issue a drug safety communication on the topic and announced their intentions to further investigate “pancreatic toxicity associated with the incretin mimetics.”
Allegations raised in lawsuits
Onglyza, like other diabetes medications, was designed to improve the health and lives of patients. Unfortunately, the potential risks of saxagliptin may outweigh benefits, given the life-threatening nature of heart failure and cancer.
Those who suffered complications after taking Onglyza or Kombiglyze XR may claim that AstraZeneca:
- Failed to conduct sufficient pre-market trials
- Failed to adequately warn patients and their health care providers about possible side effects
- Fraudulently or negligently marketed their medication
- Marketed their product despite having knowledge of inherent dangers
Damages available to Onglyza & Kombiglyze XR claimants
- Past, present and future medical expenses
- Loss of income
- Reduced earning potential
- Emotional trauma
- Wrongful death and funeral expenses
- Loss of consortium
- Punitive damages
Initiating litigation is no guarantee of success, but if you or a family member has suffered health complications or heart failure after taking Onglyza, our lawyers can assess the merits and potential worth of your dangerous drug lawsuit during a free case evaluation.
Questions about filing a drug injury lawsuit?
Over the past five years, The Sanders Firm has procured more than $200 million in settlements and verdicts on behalf of our clients. Put our vast experience and perseverance to work for you and your family.
To learn more about filing a Kombiglyze XR or Onglyza lawsuit, call 1-800-FAIR-PLAY to schedule a confidential consultation.
- WebMD, Onglyza, http://www.webmd.com/drugs/2/drug-152753/onglyza-oral/details
- Onglyza.com, Possible side effects of ONGLYZA https://www.onglyza.com/side-effects.html
- Reuters, AstraZeneca's diabetes drug Onglyza may increase death rate –FDA http://www.reuters.com/article/2015/04/10/us-astrazeneca-onglyza-fda-idUSKBN0N117620150410#jkm15RZ5rAwMVbIv.97
- Reuters, FDA panel backs safety updates for AstraZeneca, Takeda drugs, http://www.reuters.com/article/2015/04/14/us-astrazeneca-onglyza-fda-idUSKBN0N51U920150414
- FDA, Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA to Review Heart Failure Risk http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385471.htm