Onglyza Lawsuit Alleging AstraZeneca and Bristol-Myers Squibb Failed to Provide Proper Warnings
Another lawsuit was recently filed in the US District Court for the Northern District of Georgia alleging that a Georgia woman suffered heart failure that was caused by the diabetes drug Onglyza. The complaint, which was filed against the drug makers AstraZeneca and Bristol-Myers Squibb on July 24, claims that the drug was defective because it failed to adequately warn consumers and the healthcare community about the risks of heart failure when taking the drug. The complaint was filed on behalf of Cynthia Turner who alleged she took the medication from 2013 to 2014 and it caused her to develop heart failure, congestive heart failure and other cardiac injuries.
The Complaint specifically alleges:
Defendants marketed, promoted, distributed, and sold unreasonably dangerous and defective prescription Saxagliptin to health care providers empowered to prescribe and dispense to consumers, including Plaintiff, without adequate warnings and other clinically relevant information and data. Through both omissions and affirmative misstatements, Defendants misled the medical community about the risk/benefit balance of Saxagliptin, which resulted in injury to Plaintiff
View the full version of the filed complaint HERE.
Onglyza was developed by AstraZeneca and Bristol-Myers Squibb and approved by the FDA in July 2009 for the treatment of type 2 diabetes. The FDA launched an investigation concerning Onglyza and potential cardiac risks associated with the drug after the publication of the SAVOR study by the New England Journal of Medicine in 2013. Read more about the SAVOR study HERE. Ultimately the FDA required the makers of the drug to add warnings to the labels of all saxagliptin-based drugs, including Onglyza, warning patients and their doctors that the drug may cause heart failure.
The FDA’s actions came after an in-depth evaluation of the studies and clinical data linking Onglyza to congestive heart failure. In April 2015 the FDA’s FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 for stronger warnings to be added to the drugs labeling about the cardiac risks. Read more about the FDA’s investigation HERE. Their review included looking at two large clinical trials involving patients with heart disease that found the saxagliptin or alogliptin groups were at a higher risk of being hospitalized for heart failure than the placebo group.
These risks are particularly important to healthcare providers and patients when doing a risk/benefit analysis to determine the most effective and safest drug for a particular patient. The Turner complaint is similar to a growing number of other complaints alleging that AstraZeneca and Bristol-Myers Squibb failed to warn patients and the medical community of the heart failure risks associated with Onglyza. Read more about the other lawsuits filed HERE.
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If you or a loved one have suffered heart failure, congestive heart failure, cardiac complications or death while taking ONGLYZA or KOMBIGLYZE XR to treat type 2 diabetes you may be entitled to compensation. Please contact us today.
There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner. Your state of residence, when you ingested the drug and when you experienced injuries could all affect how much time you have to file.
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