Heart Failure is just the latest possible health risk for Onglyza and Kombiglyze XR users. A recently filed lawsuit suggests the drug manufacturer knew of potential heart related side effects but failed to adequately warn the public and medical community.
If you or someone you love have experienced heart failure, congestive heart failure, cardiac failure or death while taking Onglyza or Kombiglyze XR, compensation may be available from the drug manufacturer. You or your loved one may be entitled to damages for medical expenses, wage loss, pain and suffering, loss of enjoyment of life, and loss of consortium. Contact us today at 800-530-9800 for a free consultation. We are standing by 24/7, waiting to assist. It costs nothing out-of-pocket to file your claim.
Lawsuit Alleges Makers of Onglyza and Kombiglyze XR Hid the Risk of Heart Failure
February 23, 2017 – A new lawsuit has been filed by Sanders Phillips Grossman in the U.S. District Court for the Southern District of Texas against Bristol-Myers Squibb Company, AstraZeneca-Pharmaceuticals and McKesson Corporation over the companies’ alleged failure to warn consumers and the medical community of the risk of heart failure for diabetes patients using Onglyza and Kombiglyze XR.
The plaintiff, Wrendell Chester used both Onglyza and Kombiglyze XR for approximately five years between 2010-2015 and suffered heart failure, congestive heart failure and acute hypoxic respiratory failure allegedly due to the two drugs. He has been left with significant injuries.
“At no time during the development of its Saxagliptin drugs did Defendants perform adequate studies to determine if their drug, and its drastic alterations of the natural incretin hormone cycle, may cause increased risks of cardiovascular related adverse events,” the lawsuit states. “Such studies are essential when developing, and then marketing, diabetic drugs to individuals already at an increased cardiovascular risk.”
Onglyza was approved for use by the FDA in July 2009 for the treatment of type-two diabetes. Kombiglyze XR is a longer acting version which combines Onglyza with metoformin, an older diabetes drug. In 2012, Onglyza generated more than $700 million in sales.
In February 2014, the FDA performed a safety review into heart risks after the New England Journal of Medicine published a study that found increased hospitalizations for heart failure in patients who had taken Onglyza vs. those who had been given a placebo.
In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended by a vote of 14-1 for stronger warnings of Onglyza’s heart failure risks after reviewing clinical data that suggested patients may have a higher risk of hospitalization for heart failure as well.
The FDA issued a drug safety communication on April 5, 2016 which required heart failure warnings for Onglyza and Kombiglyze XR, as well as other diabetes drugs Nesina, Kozano and Oseni, all medications within a class called dipeptidyl peptidase-4 (DPP-4) inhibitors.
The lawsuit alleges negligence, failure to warn and breach of warranties.
Case No. 4:17-cv-00316, Texas Southern District Court
Onglyza Is Used To Treat Type II Diabetes
Onglyza (Saxagliptin) was approved in for the treatment of type 2 diabetes in 2009. The medication, a joint effort between AstraZeneca and Bristol-Myers Squibb is a member of a class of medications known as incretin mimetics. Normally the body produces incretin hormones to trigger the release of insulin following a meal. Incretin mimetics work by mimicking the incretin hormones to trigger a release of insulin in diabetics. Since its release in 2009, Onglyza has quickly become a strong selling drug, topping $700 Million in sales in the year 2011.
Onglyza Usage Comes With Serious Risks
Onglyza has been linked to more than one serious health concern. For some time studies have suggested a link between Onglyza use and pancreatitis which can lead to pancreatic cancer. A 2013 study in Diabetes (a medical journal) showed an increase in pancreatic mass and precancerous cell changes in users of incretin mimetics like Onglyza. More recently there has been evidence of an increased risk of heart failure due to Onglyza use. In September of 2013, The New England Journal of Medicine published a study in which researchers found Onglyza led to an increased rate of hospitalization due to heart failure.
Heart failure is a serious condition which occurs when the heart is unable to pump an adequate amount of blood to fulfill the body’s needs. In can occur in two varieties, either the heart is unable to fill with enough blood, or the heart cannot pump with enough force to supply oxygenated blood to the entire body. Symptoms of heart failure include:
- Shortness of breath
- Irregular heart beat
- Persistent cough
- Swelling of the abdomen, legs or feet
- Chest pain
The FDA itself began to look into the link between Onglyza and heart problems. This investigation, which could result in regulatory action such as an update warning label or a recall, will involve a review of the data from the SAVOR trial. The findings of the SAVOR trial were first reported in August of 2013 and showed a 27% increased risk of hospitalization for heart failure among Onglyza users.
In addition to Pancreatitis and heart failure, there is evidence that Onglyza users may be at an increased risk of thyroid cancer. Onglyza belongs to the class of drugs known as incretin mimetics which includes several drugs whose users have reported instances of thyroid cancer to the FDA. In fact, the FDA issued a safety warning in 2011 about a possible link between thyroid cancer and Victoza (liraglutide) after a study showed doses of the incretin mimetic caused rats to develop malignant thyroid cancer. While research is still ongoing, the evidence of a possible link between incretin mimetics like Onglyza and an increased risk of thyroid cancer is troubling.
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