Kombiglyze and Onglyza Lawsuit

The list of type 2 diabetes medications that were initially believed to be safe and later discovered to carry significant disease risk is a long one, and it recently got longer. In April 2015, the U.S. Food and Drug Administration (FDA) advisory committee voted to warn consumers about two other diabetes drugs, Onglyza and Kombiglyze XR, after a study published in the New England Journal of Medicine (NEJM) linked the medicines’ active ingredient, saxagliptin, to heart failure. A subsequent independent FDA analysis of the study data found “a potential increased risk of all-cause mortality [death from any cause] in saxagliptin-treated subjects.”

“…the rate of hospitalization for heart failure was increased.”

New England Journal of Medicine study: Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus

nejm-heart-failure

On October 29, 2015, a woman in Chicago filed an Onglyza lawsuit in Cook County Circuit Court against AstraZeneca, the maker of Onglyza, alleging that her mother, Lillie Ree Gibson, died of heart failure in 2013 as a result of taking the diabetes medication. Gibson began taking Onglyza after the medication was prescribed by a doctor in 2010. A year later, she was diagnosed with heart failure.

If you are experiencing health problems as a result of taking Onglyza or Kombiglyze, the following will help you better understand your legal rights and answer questions about whether filing an Onglyza lawsuit is right for you.

What is Onglyza?

OnglyzaOnglyza and Kombiglyze belong to a class of type 2 diabetes medications called DPP-4 inhibitors. DPP-4 is short for an enzyme (a protein in the body that causes certain chemical reactions) called dipeptidyl peptidase IV. When someone eats, a hormone is produced that causes the pancreas to release insulin. This hormone, known as incretin, or GLP-1, is quickly destroyed by DPP-4. Saxagliptin prevents DPP-4 from destroying the hormone, so more insulin is released into the blood, where it can do its job of controlling blood sugar levels.

Onglyza and Kombiglyze are sometimes referred to as incretin mimetics, but, strictly speaking, they are not. Incretin mimetics (Byetta and Victoza are examples of this class) have a different mode of action.

One might think of GLP-1 as a key that unlocks the doors where insulin is stored. It works by attaching to receptors on cells in the pancreas, causing the release of insulin. DPP-4 inhibitors like saxagliptin prevent DPP-4 from breaking the key. Incretin mimetics are like another key that opens the same pancreatic doors. It attaches to the same receptors. But DPP-4 cannot break this key. The term “incretin mimetic” is also sometimes used as a general term for diabetes drugs that are based on the effect of GLP-1.

 Kombiglyze and Onglyza Heart Failure: Has the Risk Been Hidden?

News of saxagliptin’s dangerous side effects might well have been expected. Individuals and physicians seeking the truth about type 2 diabetes drugs have often been blocked by pharmaceutical companies and in some cases even the Food and Drug Administration itself. Several best-selling diabetes medications have been found to increase the risk of other serious conditions, including cardiovascular disease and various forms of cancer. Onglyza and Kombiglyze are no different in this regard.

nejm-onglyza-webpageBut for many consumers, news of saxagliptin’s dangerous side effects is little to unknown, as pharmaceutical companies have concealed the dangerous side effects of their diabetes drugs and actively prevented consumers from finding out the truth. For patients who have been harmed, their last resort frequently is an Onglyza lawsuit.

Kombiglyze and Onglyza Heart Failure Studies

Due in part to the FDA’s experience with the type-2 diabetes medication Avandia, the agency now requires pharmaceutical companies to engage in studies to investigate the cardiovascular risks of their type-2 diabetes medications before and after they have been approved. The NEJM study (known as the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus trial, or SAVOR) was one such agency-required study. It was led by Dr. Benjamin Scirica, a cardiologist at Harvard Medical School in Boston, and involved 16,492 patients with type 2 diabetes.

The investigators found that Onglyza did not affect the rate of ischemic events. Ischemia is a decreased blood flow to the heart muscle and brain associated with heart attacks and strokes. However, Onglyza was tied to a 27 percent increased rate of hospitalization for heart failure, a serious condition in which the heart’s ability to pump blood is impaired. It is incurable and progressively leads to shortness of breath, fatigue, and difficulty engaging in ordinary activities, such as walking.

Second Study Confirms Onglyza Heart Failure Risk

In December of 2014, the journal Clinical Therapeutics published the results of a systematic review of evidence linking DPP-4 inhibitors, including saxagliptin, to heart failure. Data from insurance and hospital databases was combined with data from multiple published trials, including the SAVOR trial, then analyzed to see if DPP-4 inhibitors were associated with heart failure. In total, 100,102 patients were involved in the review. According to the doctor who conducted the review, “these agents may increase the risk of hospitalization for heart failure.”

Kombiglyze and Onglyza Heart Failure – The “Real” Side Effect

At a presentation for the American Heart Association in November of 2013, Dr. Scirica said he believed that the heart failure found in the NEJM study is a “real” side effect of Onglyza.

Even experts with the drug’s maker, AstraZeneca, concede there is a problem. On April 14, 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met to review the NEJM study results and the evidence linking saxagliptin to heart failure and death. At the meeting, Dr. Bertram Pitt, a former professor of medicine at the University of Michigan and a consultant to AstraZeneca, told the committee members that it was clear “there is a signal that’s emerging for heart failure.” Dr. Bertram was invited to speak by AstraZeneca’s vice president for global medicines’ development, Howard Hutchinson. Dr. Bertram listed several possible mechanisms by which Onglyza might produce heart failure, including the death of heart muscle cells.

Following the meeting, 14 of the 15 committee members voted to update the Onglyza and Kombiglyze labels to warn consumers of the possibility of an increased risk of heart failure.

Pancreatitis and the Risk of Pancreatic Cancer

In March of 2013, the FDA warned that diabetes drugs in the incretin mimetic class have been linked with pancreatitis (inflammation of the pancreas) and pre-cancerous cell changes in the pancreatic duct. The agency included saxagliptin (Onglyza, Kombiglyze) and a number of other DPP-4 inhibitors among the incretin mimetics it is investigating. The warning came after a study of over 2,500 patients found that treatment with incretin mimetics doubled the risk of acute pancreatitis. The authors of the study, which was published in JAMA Internal Medicine, recommended long term studies to determine whether these diabetes medicines increase the risk of pancreatic cancer.

cancer-onglyza-lawsuitShortly after the FDA published its warning, the non-profit Institute for Safe Medication Practices (ISMP) released its own report on the evidence linking saxagliptin and other incretin mimetics to pancreatitis. The ISMP analyzed serious adverse events reported to the FDA Adverse Event Reporting System (FAERS) involving two incretin mimetics, exenatide (Byetta) and liraglutide (Victoza), and three DPP-4 inhibitors, saxagliptin (Onglyza, Kombiglyze), sitagliptin (Januvia), and linagliptin (Tradjenta).

Institute investigators compared the adverse reactions reported for these drugs to those reported for other antidiabetic medicines with different modes of action. Over a one year period, there were 1,732 reports filed for the five diabetes medicines, including 831 cases of pancreatitis and 105 cases of pancreatic cancer. It has been estimated that between one and 15 percent of adverse reactions are reported to FAERS, with six percent reported on average. There were 574 reports filed on the comparison drugs, with 18 instances of pancreatitis and two cases of pancreatic cancer reported. The ISMP report concluded: “These results add additional scientific weight to the association of all five GLP-1 agents with reports of pancreatitis.” The scientists also repeated the recommendations of the JAMA study authors, calling for “further investigation” of the drugs.

In 2014, a couple in Kentucky filed an Onglyza lawsuit alleging that several incretin mimetic class diabetes medications caused the plaintiffs to develop pancreatic cancer. In their Onglyza lawsuit, the couple claims they never would have taken the mimetic class diabetes medications had they, or their doctor, been warned about the risk of developing pancreatic cancer.

Does Onglyza Cause Thyroid Cancer?

At this point the little research available raises concerns but provides no clear answers.

On this question, it is important to remember that DPP-4-inhibitors and incretin mimetic drugs have different means of operation.

As explained above, DPP-4 inhibitors like Onglyza and Kombiglyze prevent the GLP-1 “key” from being broken. Incretin mimetics are like another key that fits the same pancreatic doors (receptors). Incretin mimetics are sometimes called GLP-1 receptor agonists (an agonist is a chemical that binds to a receptor and triggers a reaction). An excellent enlargeable illustration showing how incretin mimetics and DPP-4 inhibitors work is available on the website of Diabetes Care, a journal published by the American Diabetes Association.

The different modes of action of these two types of drugs may explain what has been found so far in terms of a link to thyroid cancer. A 2015 review of cancer risk associated with incretin mimetics and DPP-4 inhibitors, including Onglyza, reported that analyses of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) have linked both types of drugs to a “significantly higher risk of pancreatic cancer.” But a higher risk of thyroid cancer was only associated with incretin mimetics (GLP-1 receptor agonists) not DPP inhibitors.

The above-mentioned investigation by the Institute for Safe Medication Practices found thyroid cancer was associated with two incretin mimetics: exenatide (Byetta) and liraglutide (Victoza). Byetta was linked with 14 cases of thyroid cancer, Victoza with 17 cases. In a separate ISMP Medication Safety Alert, the watchdog group stated their results were statistically significant for Byetta and Victoza compared to the control drugs. The two ISMP reports were in conflict regarding saxagliptin, with one report saying there was one case of thyroid cancer linked to saxagliptin and the other saying it was linked to another DPP-4 inhibitor, sitagliptin.

Does this mean there is no cause for concern with Onglyza? Unfortunately, no. As pointed out in a 2013 article in Diabetes Care, antidiabetic drugs have a history of being released with no long-term research showing benefits. Evidence of harm has been hidden or ignored and regulators have been slow to react. Drugs like Onglyza and the incretin mimetics are relatively new to the market and little is known about their long-term effects. Moreover, Onglyza operates on the same GLP-1 pathway as the incretin mimetics, which have been linked to thyroid cancer. Lastly, the research into DPP-4 inhibitors, incretin mimetics, and thyroid cancer was based on data in the FDA’s adverse reporting system. But only a small percentage of adverse events are reported to that system.

Patients taking Onglyza or Kombiglyze are advised to be on the alert for signs of thyroid cancer. Symptoms (from the Mayo Clinic) include

  • A lump that can be felt through the skin on the neck
  • A change in the voice
  • Hoarseness
  • Difficulty swallowing
  • Pain in the neck and throat
  • Swollen lymph nodes in the neck

If you have experienced any of these symptoms after taking Onglyza or Kombiglyze, contact a personal injury attorney at Baum, Hedlund, Aristei & Goldman today to learn more about filing an Onglyza lawsuit.

KombiglyzeKombiglyze and Onglyza Side Effects

In addition to its cardiovascular effects which can cause heart failure, and pancreatic and thyroid cancer, saxagliptin has been linked to several other serious side effects:

  • Pancreatitis
  • Acute Pancreatitis
  • Hemorrhagic Pancreatitis
  • Necrotizing Pancreatitis
  • Kidney Complications
  • Renal Failure
  • Severe joint pain

Common Onglyza and Kombiglyze Side Effects:

  • Upper respiratory tract infection
  • Urinary tract infection
  • Headache

 Other, less severe Kombiglyze and Onglyza side effects may include:

  • Allergic reactions
  • Blurred vision
  • Burning in the eyes
  • Clay-colored stools
  • Confusion
  • Dark colored urine
  • Difficulty breathing
  • Drowsiness
  • Dry mouth
  • Dry skin
  • Fast heart rate
  • Fever
  • Hives
  • Increased thirst
  • Increased urination
  • Irregular heartbeat
  • Itching
  • Jaundice
  • Loss of appetite
  • Memory problems
  • Narrowing of the airways
  • Severe joint pain
  • Severe pain in the upper stomach
  • Severe skin reactions
  • Skin pain
  • Sore throat
  • Suffocation
  • Swelling of the face or tongue
  • Unusual tiredness
  • Urinating less than usual or not at all
  • Weight gain
  • Weight loss

 Other Saxagliptin Side Effects – Lactic acidosis

The Onglyza and Kombiglyze XR labels both warn of serious allergic reactions that can cause facial swelling, narrowing of the airways and suffocation.

Because Kombiglyze combines saxagliptin with metformin, its label also warns of a rare but serious complication known as lactic acidosis, a condition in which lactic acid builds up in the body. Both Kombiglyze XR and metformin carry a black box warning for lactic acidosis (LA). According to the Kombiglyze XR label, LA is fatal in about half of all cases. Initial symptoms of lactic acidosis may be subtle and include malaise (a general feeling of discomfort), muscle aches, difficulty breathing, sleepiness, fatigue, abdominal distress and vomiting, and irregular heartbeat.

Since metformin is mainly excreted by the kidneys and lactic acid levels can rise when the liver is damaged, Kombiglyze is not recommended for patients with impaired kidney or liver function.

On August 8, 2015, the FDA issued a safety alert warning that several type 2 diabetes medicines, including saxagliptin,”may cause joint pain that can be severe and disabling.” The warning stated that the agency has added a new “Warning and Precaution” about this side effect to the labels of all the medicines in the DPP-4 class.

Do I Have an Onglyza Lawsuit?

It is not uncommon for consumers to discover that the health problems they are experiencing are actually drug side effects that were concealed for years. If you are experiencing health problems as a result of taking Onglyza or Kombiglyze, filing an Onglyza lawsuit may be the best way to obtain justice. An Onglyza lawsuit can also be a powerful tool for unlocking pharmaceutical company secrets and ensuring that more people won’t be harmed by this dangerous drug.

If you have taken a saxagliptin, such as Onglyza or Kombiglyze XR, and are suffering from heart failure or other cardiovascular side effects, you may be considering whether to file an Onglyza lawsuit.

The attorneys at Baum, Hedlund, Aristei & Goldman have decades of experience uncovering fraud and negligence by major pharmaceutical companies. Our team of prescription drug injury attorneys can review your case at no charge and help you decide if filing an Onglyza lawsuit is your best course of action. All consumers have the right to be fully informed about the medications they take, and our attorneys have dedicated their practices to protecting and enforcing that right.

Filing an Onglyza lawsuit can be a crucial first step towards uncovering the complex tactics used by the drug makers to hide known side effects. Contact us today to consult with a Baum Hedlund attorney about filing an Onglyza lawsuit.

U.S. Food and Drug Administration Documents Related to Onglyza and Kombiglyze

Contact us today to consult with a Baum Hedlund attorney about filing an Onglyza lawsuit.

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