Bristol-Myers Squibb and AstraZeneca hid Onzyglza heart failure risks: Lawsuit. According to Robert Curtis’ lawsuit claims, Bristol-Myers Squibb and AstraZeneca pharmaceutical companies hid the potential Onglyza heart failure risks from diabetic patients and their doctors by providing false and misleading information about the safety of their new diabetes drug.
Curtis filed his product liability complaint in the U.S. District Court for the Eastern District of Kentucky, claiming that he developed heart failure after taking Onglyza and Kombiglyze XR, which combines the active ingredient in Onglyza with metformin, an older more established diabetic medication.
Curtis alleges that the drug markers know about the link between Onzyglza and heart failure, yet continued to market Onglyza and Kombiglyze XR as safe and effective.
What is Onglyza?
Onglyza (saxagliptin) was developed by AstraZeneca and Bristol Myers Squibb, and released in 2009 for treatment of type 2 diabetes. Concerns about the potential side effects of Onglyza have led the FDA to add new warnings about the heart risks to the drug label in 2016.
Onglyza belongs to a new class of diabetic drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. These medications help control blood sugar by blocking the action of DPP-4, an enzyme that destroys “incretins.” Incretins are hormones that stimulate insulin secretion in response to meals.
Some experts state that Onglyza lacks sufficient benefit to justify the heart failure risks since other safer diabetes drugs are available that are not associated with the same side effects.
Onglyza Heart Injury Risks
The FDA launched an investigation in 2014, after the SAVOR study, published in the New England Journal of Medicine in 2013.
In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended stronger warnings about the increased risk of Onglyza heart failure side effects after reviewing data from two large clinical trials.
The two large clinical trials found that diabetic patients taking saxagliptin or alogliptin were at a higher risk of being hospitalized for heart failure than those given a placebo or a sugar pill.
The FDA added Heart Failure warnings for Onglyza in April 2016. The FDA also has urged patients and healthcare professionals to report Onglyza heart failure side effects to the FDA MedWatch program.
Onglyza Multidistrict Litigation
In February, the U.S. Judicial Panel on Multidistrict Litigation centralized and consolidated all federal Onglyza cases in the U.S. District Court for the Eastern District of Kentucky, as part of a federal MDL, or multidistrict litigation, under District Judge Karen K. Caldwell.
MDL No. 2809, IN RE: ONGLYZA (SAXAGLIPTIN) AND KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN) PRODUCTS LIABILITY LITIGATION.
If you or a loved one has taken Onglyza and suffered heart failure and/or death, you may have an injury claim against AstraZeneca. To learn more about your legal rights, call Dr. Shezad Malik Law Firm at 888-210-9693 for a free case review. Dr. Shezad Malik Law Firm is based in Dallas, Texas and is investigating and accepting Onglyza Heart Failure injuries nationwide.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.