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Onglyza, Kombiglyze and the Risk for Heart Failure

Onglyza, Kombiglyze and the Risk for Heart Failure – What They Knew, When They Knew It

In 2016 it was reported that 1 out of 11 people will suffer from diabetes and more than 30 million people in the U.S. alone have diabetes. Onglyza XR and Kombiglyze XR (saxagliptin) are oral medications used to lower blood sugar in patients with Type 2 Diabetes and are classified as DPP-4 Inhibitors. Unfortunately, these medications have been linked to heart failure, extended hospitalization, surgery, congestive heart surgery, cardiac arrest, and even death.

What They Knew

Onglyza is manufactured by the Bristol-Myers Squibb Company and was approved for market by the FDA in 2009. Kombiglyze was approved in 2010 and is manufactured by Bristol-Myers Squibb Company and AstraZeneca. Saxagliptin is a new new class of diabetic drug called dipeptidyl peptidase – IV (DPP-IV) which targets the slow release and availability of certain incretin hormones. Previous diabetic medications work by controlling hyperglycemia through stimulation of insulin that is released from the pancreas. Saxagliptin works by slowing down the incretin hormone (GLP-1) allowing for more glucose control. This lowers blood sugar levels by helping the body increase insulin production after meals.

The problem is that the GLP-1’s time in your system is approximately two minutes without Saxagliptin exposure but survives for at least three hours during exposure to this drug. Saxagliptin manipulates the hormone’s effect by enabling the process to continue for a much longer period of time than what the human body may process safely. This extended period of time can lead to the potential for critical heart complications.

When They Knew It

In December 2008, the FDA acknowledged that Saxagliptin drugs posed cardiovascular risks and stated that these companies that are creating new anti-diabetic medications for the treatment of type 2 diabetes should perform more studies to prove that the medications are safe. Unfortunately, Bristol-Myers Squibb Company and AstraZeneca ignored this request from the FDA and sold Saxagliptin for nearly five years before completing an adequately designed study focusing on the risks of heart failure, congestive heart failure, cardiac failure, and death related to those heart conditions.

At no time during the development of its Saxagliptin drugs did the pharmaceutical companies perform adequate studies to determine if their drug – and its drastic alterations of the natural incretin hormone cycle – could cause harmful effects to the heart. Such studies are essential when developing, and then marketing, diabetic drugs to diabetic individuals who are already at an increased risk for cardiovascular complications.

What Can You Do?

If you took Onglyza XR and Kombiglyze XR after 2009, were on the drug for at least 10 days, and suffered from heart failure, extended hospitalization, surgery, congestive heart surgery, cardiac arrest or a loved one died while taking this medication, then you may be able to make a claim. The pharmaceutical companies didn’t properly test this new medication before putting it on the market and now countless innocent patients have suffered from cardiac complications. Contact us today to see if we are able to help you.

Onglyza & Kombiglyze Warnings In The News

BREAKING (4/4/18): More Type 2 Diabetics add Complaints to Ongoing Onglyza Litigation

In the past month, two more Onglyza and Kombiglyze lawsuits were filed on behalf of diabetes patients who claim the manufacturer concealed information linking the diabetes drug to an increased risk of heart failure and failed to warn about its alleged potential to cause serious heart problems.

Read Full Article

10/7/17: Heart Failure Warning Added to the DPP-4 Inhibitor Class of Drugs

Sitagliptin (Januvia) is a DPP-4 antidiabetic oral agent for treating type 2 diabetes. A new warning label regarding the risk of developing heart failure in patients with cardiovascular disease was issued to this drug by the FDA in September 2017.

Read Full Article

4/5/16: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin

A U.S. Food and Drug Administration (FDA) safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. Heart failure can result in the heart not being able to pump enough blood to meet the body’s needs. As a result, we are adding new warnings to the drug labels about this safety issue.

Read Full Article

Onglyza & Kombiglyze Complaints & Damages

4/4/18: Curtis v. Bristol-Myers Squibb Co.; Astrazeneca Pharmaceuticals, LP; Mckesson Co. (KY)

The use of Saxagliptin can cause heart failure, congestive heart failure, cardiac
failure, death from heart failure, and other serious health conditions. Plaintiff ingested Saxagliptin, and as a result of use of the drug suffered injuries.

Read Full Case

7/24/17: Turner v. Bristol-Myers Squibb Co. (GA)

This is an action for damages relating to the Defendants’ design, manufacture, sale, marketing, advertising, promotion, labeling, packaging, and distribution of their drug Saxagliptin. Defendants sell their Saxagliptin drug under the brand names Onglyza and Kombiglyze XR. Saxagliptin, in any of its forms or products, including Onglyza and Kombiglyze XR, shall herein be referred to as “Saxagliptin.”

Read Full Case

12/4/17: Hardy v. Bristol-Myers Squibb Co. (AL)

The use of Saxagliptin can cause heart failure, congestive heart failure, cardiac
failure, death from heart failure, and other serious health conditions. Plaintiff ingested Saxagliptin, and as a result of use of the drug suffered injuries.

Read Full Case

GET YOUR FREE Onglyza/Kombiglyze CASE REVIEW TODAY

Onglyza & Kombiglyze settlements are now being negotiated, but there is a limited window to pursue help. If you think you, a friend, or a family member may qualify, get your free case review today… before it’s too late!

  • * Submit now to learn if you may be eligible for a cash settlement or call (800) 511-3838 now.

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Crystal Mesh – Audiobook

Dr. Chris DeArmitt, who is a consultant to the top technology firms in America, told Sky News: “I see an absolute disregard for proper testing. Testing is way less than you would see on a vacuum cleaner or a washing machine. It’s shocking. I’ve never seen anything like it in my career.”

No Testing, Fast Approval, Injured Patients: Is the FDA Finally Listening to Mesh Survivors?

You might be wondering “Testing for what?” You would probably be shocked to find out that “more than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to FDA clearance for distribution or sale,” shares Consumers Union project director Lisa McGiffert in an article from the Fowler Tribune.

This loophole in the FDA is called the 510(k) process and it has allowed millions of patients to be irreparably harmed – and even killed – by the very device that was intended to help them. Now after several decades of patient injuries, billions of dollars being fought over in court, and countless devices being pulled from market (too little, too late, we might add), the FDA is only now looking into changing this horrific flaw in their system.

What is the FDA’s 510(k) Process?

The FDA’s 510(k) process allows medical devices companies to quickly fast-track a product to market based on a pre-approved product. This idea came about decades ago with the purpose to promote innovation but has instead become a way for big companies to slip their products to market for high profits while avoiding expensive testing. This has caused several inexcusable problems to arise. Here’s one tragic example: 

Transvaginal Mesh

A medical device can be approved for market based on a previous model, even one that was recalled. This is what happened in the huge debacle involving vaginal mesh. Protegen was the first vaginal mesh product on the market, but was recalled due to patient harm. However, even after it was pulled, dozens of additional mesh devices were sold and implanted in patients based on this poor design. Currently, hundreds of thousands of women are suffering from mesh and many will have to live with chronic pain, the impossibility of holding down a job, and the inability to have sex with their partners for the rest of their lives. 

But this story includes many more products beyond vaginal mesh-like IVC filters to prevent blood clots, Essure female sterilization devices, hip replacement products, and countless others.  The New York Times reports that these fast-tracked devices have caused 80,000 deaths and more than two million injuries.

Change is in the Air 

Fortunately, with documentaries like The Bleeding Edge, social media groups criticizing the FDA’s process, and advocacy groups, the FDA is reevaluating how it approves devices for market. According to the JAMA (Journal of the American Medical Association) Network,

“For premarket review of 510(k) devices, on February 1, 2019, the FDA released a Final Guidance Document for the ‘Safety and Performance Based Pathway.’ This optional pathway consists of using criteria that involve conformance to FDA-recognized consensus standards, FDA guidance, and/or special controls. It enables 510(k) clearance for certain medical devices if the device meets these specific criteria, which should include safety and effectiveness (as opposed to the often ill-defined ‘substantial equivalence’ to predicate devices). The decision to use this new pathway is determined by manufacturers, although the FDA can disagree with this determination.”

While this is a step in the right direction by requiring device companies to prove safety and effectiveness, many think that these changes don’t go far enough towards protecting patient health. For instance, JAMA suggests that “legislation should mandate that 510(k) devices show improved safety and effectiveness compared with marketed devices for the same clinical purpose, using meaningful clinical criteria to gain clearance. Although these criteria will differ based on the intended use of the device, all criteria should be based on patient-oriented clinical outcomes.”

Additionally, once a product is approved for market, many times the post-market surveillance falls to the wayside. Medical devices should have a registry so that patients can know what devices are implanted in them, doctors can properly treat problems that may arise, and companies can monitor their products more effectively. Car parts are meticulously tracked, shouldn’t medical devices be all the more!?!

Too Little, Too Late

It’s great that the FDA is reviewing it’s 510(k) process that has been grossly overused and under monitored for decades, but what about those who have already been harmed by an agency that favored billion-dollar medical device companies over the health and wellness of patients?

One way that this FDA change was brought about was through the voices and bravery of those who were injured by these faulty medical devices. If you or a loved one had vaginal mesh and had corrective surgery, your voice needs to be heard. Please call Periscope Group today at (800) 511-3838. It’s time to hold medical device companies accountable for the unbearable pain they caused you. We want to hear your story and we want to help you if we can.

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Sources
“Vaginal mesh: Tests on plastic material ‘way less’ thorough than on washing machine”. Sky News. Accessed August 5, 2019. https://news.sky.com/story/vaginal-mesh-tests-on-plastic-material-way-less-thorough-than-on-washing-machine-11772530?fbclid=IwAR0ieT27Sh1V8q53Vt7y3BH2PK1M9akqoLCAFvnf1JskMeAOu10yvzgEi20
“Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices”. JAMA Network. Accessed August 5, 2019. https://jamanetwork.com/journals/jama/fullarticle/2744408?fbclid=IwAR04Fkrn-A1NbJDUkuOOOU-EhA55G5kkXUYJWGIb8y-MftOdFTQ0hrk_Bl0
“Medical Device Testing: Too Much, or Not Enough?” ADMET. Accessed August 5, 2019. https://www.admet.com/medical-device-testing-too-much-or-not-enough/

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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