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FDA Onglyza Approval
After a 52-week study conducted by AstraZeneca in 2006, they found Onglyza and Kombiglyze XR (both saxagliptin medications) helped break down the hormones needed to control blood sugar levels. Both drugs are a member of a class of drugs called DPP-4 inhibitors. DPP-4 is an enzyme that raises those hormones, and thus, leads to an increase in insulin.
When AstraZeneca submitted this study to the FDA for approval, the main side effect they noted was an upper respiratory infection. There wasn’t any mention of heart failure.
Instead, the FDA approved Onglyza in 2009 and Kombiglyze XR in 2010. Along with diet and exercise, these medications, which are marketed and sold through AstraZeneca’s work. It became instantly popular because it works to control blood sugar without weight gain.
In just a few years, profits for the drug reached $786 million. Analysts expect that figure to be closer to $3 billion. This wasn’t enough for the company. AstraZeneca recently received FDA approval to combine Onglyza with an SGLT2 Inhibitor called Forxiga. This will reach even more type 2 diabetics. SGLT2 inhibitors such as Invokana have been linked to serious kidney injuries.
AstraZeneca Knew Onglyza Dangers All Along
Ongoing litigation alleges that AstraZeneca likely knew Onglyza had the potential for heart failure as early as 2006. This is three years before the FDA approved the drug. Heart failure is a potentially deadly condition. It arises when the heart does not pump blood thoroughly enough to satisfy the needs of the body. According to the Centers for Disease Control and Prevention, heart failure contributed to 1 in every 9 deaths in the U.S. in 2009. Half of all people who develop heart failure will die within 5 years of the diagnosis, according to the CDC.
The FDA didn’t even know that Onglyza was killing people until 2014. This is 5 years after approval. This is when the FDA demanded an investigation into the link between saxagliptin use and heart failure.
Onglyza Heart Failure Studies
In 2013, the SAVOR study found a possible link between Onglyza and an increased risk of heart failure. The study revealed a 27% increased risk of hospitalization for heart failure. Plus, more people died while using Onglyza of heart-related incidents.
An additional study (EXAMINE) revealed that 35 out of every 1,000 patients using saxagliptin-containing drugs were hospitalized. This is a 35% increased risk of heart failure. Ten percent more than those who received the placebo.
In February of 2016, the Food and Drug Administration issued a mandatory label change for Onglyza and Kombiglyze XR to reflect the increased risk of heart failure. Along with the mandated label changes for Onglyza and Kombiglyze XR reflecting the heart failure risk, the FDA strongly recommends medical personnel to discontinue all saxagliptin-containing medication when a patient develops heart failure. They also advised of additional warning signs or symptoms that will need to be evaluated by a healthcare professional right away:
- Unusual shortness of breath during daily activities
- Trouble breathing when lying down
- Tiredness, weakness, or fatigue
- Weight gain with swelling in the ankles, feet, legs, or stomach
Heart failure is a potentially deadly condition that arises when the heart does not pump blood thoroughly enough to satisfy the needs of the body. According to the Centers for Disease Control and Prevention, heart failure contributed to 1 in every 9 deaths in the U.S. in 2009. Half of all people who develop heart failure will die within 5 years of the diagnosis, according to the CDC.
Signs and symptoms of heart failure include:
- Shortness of breath/difficulty breathing
- Swelling in the feet, legs, arms or stomach
- Feeling tired or weak
FDA Finds Possible Link to Onglyza & Pancreatic Cancer
In April 2013, the FDA warned that Onglyza and similar drugs may increase the risk of pancreatitis. The drug may be linked to the development of pre-cancerous tissue in the pancreas. The agency urged further investigation.
Pancreatitis and pancreatic cancer have the following symptoms:
- Sudden weight loss
Pancreatic Cancer Studies
A 2013 study observed pre-cancerous cells in autopsied pancreases of people taking Onglyza and similar drugs. According to the study, one of the claims of DPP-4 drugs is that they increase the number and size of beta cells in the pancreas. These cells help secrete insulin. When someone has Type 2 diabetes, the beta cells shrink or die and lose their ability to produce insulin.
The researchers found the drugs did indeed increase the number of beta cells, but that the cells were abnormal. They also found small, benign tumors called adenomas that can become malignant. This only happened to Type 2 diabetics taking DDP-4 drugs like Onglyza.
Current Onglyza Lawsuit Litigation
Currently, over 80 claims that Onglyza caused heart failure are pending in 30 federal jurisdictions. The JPML requested those cases be sent to the U.S. District Court, Eastern District of Kentucky under Karen K. Caldwell. Consolidating the cases reduces duplicate discovery into common issues, avoid conflicting pretrial rulings from different courts, and to serve the convenience of the parties, witnesses, and the courts.
The JPML selected the Eastern District of Kentucky as the most suitable venue since it is relatively accessible and the longest-pending action is proceeding in that district. The court consolidates these cases into multi-district litigation called MDL No. 2809. Also, as part of the coordinated pretrial proceedings, Judge Caldwell will establish a bellwether process. This is where the judge will schedule a small group of cases for early trial dates. These trials help gauge how juries may respond to certain evidence and testimony repeated throughout the litigation. Currently, due to COVID-19, litigation has experienced a time setback. In November, motions to compel for documents in the discovery process was granted. However, the manufacturer still have not produced the necessary documents. Therefore, additional motions were filed.
On March 29, The Michael Brady Lynch Firm along with Peiffer Rosca Wolf Abdullah Carr & Kane filed Lori Stewart’s case on behalf of the estate of her mother, Agnes Stewart in the U.S. District Court for the Eastern District of California against Bristol-Myers Squibb and AstraZeneca Pharmaceuticals. Lori Stewart says the manufacturers committed wrongful death, negligence, failure to warn, and other counts against her mother.
Between February and June 2015, her mother, Agnes Stewart used Onglyza as part of her diabetes treatment, but she developed congestive heart failure in June 2015. Her daughter insists that pharmaceutical giants never warned her mother of the cardiac risks of using Onglyza and saxagliptin. Lori Stewart requested a jury trial for compensatory, general and punitive damages; incidental expenses; prejudgment interest; and for other such and further relief as the court deems just and proper.
There is also JCCP 4909 in California following a parallel track to the MDL.
Speak to an Attorney Today
If you or a loved one has been harmed by Onglyza, you need an attorney with experience helping people who have been harmed by pharmaceutical drugs. The attorneys at the Michael Brady Lynch Firm know what it takes to go up against drug manufacturers to get clients what they need.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. You may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
Case evaluations are free of cost and without obligation. Call us today at (877) 513-9517 or contact us online to speak with an attorney about your options. We may be able to get you the help you need.