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 profited greatly 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.

In fact, patients who take Onglyza (saxagliptin) to control their blood glucose levels appear to be 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 withOnglyza . 

The Pennock Law Firm specializes in pharmaceutical litigation and product liability. We are currently reviewing Onglyza and Kombiglyze XR lawsuits with patients who suspect their health concerns are linked to a potentially dangerous 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. As always, patients should always consult their physician before discontinuing any prescribed medication.

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. Onglyza, 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 containing 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.

Some of the most common side effects of Onglyza and Kombiglyze XR include:

· Headaches

· Urinary tract infections

· Upper respiratory tract infections

· Nausea

· Fatigue

· Swelling or fluid retention

The following are more severe side effects linked to Onglyza and Kombiglyze XR :

· 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.

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.”

Onglyza, like other diabetes medications, was designed to improve the health and lives of patients. Unfortunately, the potential risks of Onglyza and Kombiglyze XR 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

· With the guidance and representation of a knowledgeable drug injury attorney, plaintiffs may be able to recover substantial compensation by bringing a personal injury lawsuit against AstraZeneca.

· 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.

To learn more about filing a Kombiglyze XR or Onglyza lawsuit, call the Pennock Law Firm at (551) 200-6352 to schedule a confidential consultation.

  Fluoroquinolone antibiotics are a type of antibiotics grouped together based on their chemical properties. Though each fluoroquinolone is approved for different uses by the FDA, these antibacterial agents generally have been used to treat respiratory and urinary tract infections, as well as other types of bacterial infections.

Some of the medications that fall into the category of fluoroquinolone antibiotics are:

• Levaquin (levofloxacin)
• Avelox (moxifloxacin)
• Cipro (ciprofloxacin)
• Cipro XR (ciprofloxacin extended-release)
• Factive (gemifloxacin)
• Floxin (ofloxacin)
• Maxaquin (lomefloxacin)
• Noroxin (norfloxacin)
• Proquin XR (ciprofloxacin extended-release)
• Zagam (sparfloxacin)

Currently, some of these medications have been discontinued in their brand-name formulations, but brand-name prescriptions are still dispensed, along with many generic formulations.

Although approved by the U.S. Food and Drug Administration (FDA) to treat specific conditions, concerns are mounting that taking fluoroquinolone antibiotics may be linked to aortic dissection and aortic aneurysm. Two recent studies published by respected medical journals have demonstrated that taking fluoroquinolone antibiotics may harm the aortic wall, leading to dissection or aneurysm.

People with aortic aneurysm or dissection are likely to require hospitalization, and in some cases, surgery. One of the new studies indicates that risk of aortic aneurysm or dissection may still be significantly elevated even a year after taking a fluoroquinolone.

Nearly eight years ago, the FDA concluded that a boxed warning, the agency’s strongest type of warning, was a necessary addition to all fluoroquinolone labeling. The agency instructed manufacturers of fluoroquinolone antibiotics of the need to “add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking” fluoroquinolone antibiotics. 

The FDA has not taken any action yet regarding the recently published data indicating aortic dissection and aneurysm risk accompanying use of fluoroquinolone antibiotics. As always, patients should always consult their physician before discontinuing any prescribed medication.

Two different groups of researchers that recently have had their findings published in separate medical journals have reason to believe that fluoroquinolone antibiotics may damage certain types of collagen. This may result not only in tendon rupture, but also aortic dissection or aneurysm.

According to authors of the study published in the medical journal BMJ Open, type I and type III collagen constitute most of the collagen in the Achilles tendon as well as most (80 to 90 percent) of the collagen in the aorta.

The authors note that “Diseases of the aorta, including aortic aneurysms and dissections, are associated with alterations in collagen content, concentrations, and structure.” Because these alterations to collagen are likely the cause of tendon injuries associated with fluoroquinolone antibiotics, the authors conjecture that such changes may lead to potentially life-threatening aortic dissection and aneurysm as well.

Researchers involved in the BMJ Open study, which examined hazard ratios for tendon rupture, retinal detachment, and aortic aneurysm, found an over twofold increased hazard of aortic aneurysm in those taking fluoroquinolone antibiotics. The second study, published in the JAMA Internal Medicine ,  also found that use of fluoroquinolone antibiotics was associated with a greater than twofold risk of aortic aneurysm and dissection.

The authors of these studies suggest that physicians should weigh the possible risk of aortic aneurysm or dissection when treating patients with fluoroquinolone antibiotics.

The aorta is the major artery that carries oxygenated blood out of the heart so that it can be distributed to the rest of the body. An aortic dissection occurs when a tear forms in the wall of the aorta. Depending on the length of the tear, blood may flow between the layers of the aortic wall, potentially causing an aortic rupture, or bursting of the aortic wall. Decreased blood flow to other organs in the body may lead to other complications.

An aortic aneurysm is an abnormal bulging or enlargement of the aorta. If this bulging causes the aortic wall to burst, a person may suffer a hemorrhage (severe bleeding), a condition that is often fatal 

If you were diagnosed with an infection, took a fluoroquinolone antibiotic, and suffered an aortic dissection or aneurysm necessitating hospitalization or surgery, you may be entitled to compensation.

Or, if you are a surviving spouse or family member of someone who took a fluoroquinolone antibiotic and died from aortic dissection or aneurysm, please contact us. You may be able to receive compensation.

Initiating litigation is no guarantee of success, but if you or a family member has suffered health complications after taking Levaquin, the Pennock Law Firm can assess the merits and potential worth of your dangerous drug lawsuit during a free case evaluation.

To learn more about filing a Levaquin lawsuit, contact the Pennock Law Firmto schedule a confidential consultation.

When you take a proton pump inhibitor (PPI) to alleviate symptoms of acid reflux, or to treat a stomach ulcer or injury to your digestive tract caused by acid reflux, you may experience severe side effects you never thought possible. 

Taking a PPI — such as Nexium, Prilosec or Prevacid — may be associated with an increased risk for serious, chronic, even life-threatening side effects. As always, patients should always consult their physician before discontinuing any prescribed medication. 

If you have taken a PPI and had serious injury to or problems with your kidneys, we believe you may have a right to seek possible compensation. We are accepting clients who, after taking a PPI, suffered problems with their kidneys. 

Contact the Pennock Law Firm if you were diagnosed with one of the following severe conditions after taking a PPI: 

• Chronic kidney disease 
• Acute kidney injury, also called “acute renal failure” 
• Interstitial nephritis  
• End-stage renal failure, also called “end-stage renal disease” 

In some instances, you may have lost a loved one due to these severe side effects. You may be entitled to compensation for the loss your family members suffered. 

Proton pump inhibitors (PPIs) are a type of medication that decrease the amount of stomach acid produced by glands in your stomach’s lining. 

These prescription and over-the-counter PPI medications may be associated with an increased risk of developing serious, life-threatening kidney problems: 

• Nexium  
• Nexium 24 HR  
• Prevacid  
• Prevacid 24 HR  
• Prilosec  
• Prilosec OTC  
• Zegerid  
• Zegerid OTC  
• Dexilant  
• Dexilant SoluTab  
• Protonix  
• AcipHex  
• AcipHex Sprinkle  

Individuals may take a PPI in an attempt to alleviate symptoms of acid reflux, also called gastroesophageal reflux disease (GERD). This condition occurs when food or liquid travels up from the stomach and enters the esophagus, which is the tube leading from the mouth to the stomach. 

PPIs are also intended to ease symptoms of a stomach (peptic) ulcer. Sometimes these medications are taken to reduce uncomfortable symptoms associated with damage to the lower esophagus caused by acid reflux. 

Taking a proton pump inhibitor may increase an individual’s risk of developing chronic kidney disease, acute kidney injury or interstitial nephritis. 

Chronic kidney disease, also called CKD or chronic kidney failure, occurs gradually as the kidneys begin to lose their ability to function. The kidneys filter waste products and extra fluid from the blood. These waste products leave the body through urine. 

When the kidneys lose their ability to function, waste products and excessive fluid can accumulate in the body. If the condition progresses, kidney dialysis or a kidney transplant may be required. Left untreated, or if treatment is unsuccessful, the condition can be fatal. 

Acute kidney injury (AKI), or acute renal failure, occurs suddenly over several hours or days. The kidneys rapidly lose their ability to filter waste products, which may lead to excessively high levels of waste products and fluid imbalances in the body. 

AKI can lead to chronic kidney disease and end-stage renal disease. Immediate treatment is necessary or the condition can be fatal. 

Interstitial nephritis is another type of kidney disorder. This condition is characterized by inflammation in specific tissue in the kidneys, which interferes with how the kidneys function. In severe cases, the inflammation can lead to chronic kidney failure and cause permanent damage to the kidneys. 

Initiating litigation is no guarantee of success, but if you or a family member has suffered health complications after taking a PPI, the Pennock Law Firm can assess the merits of your dangerous drug lawsuit during a free case evaluation. 

To learn more about filing a Proton Pump Inhibitor (PPI) lawsuit, contact the Pennock Law Firm to schedule a confidential consultation.