Onglyza Lawsuits Allege Undisclosed Heart Failure Risks
Hundreds of patients suffering from diabetes type 2 and their families have filed lawsuits over undisclosed heath risks associated with Onglyza (the brand name of the drug saxagliptin) and Kombiglyze XR.
Most complaints have been filed over connections between Onglyza and heart failure, a link supported by a recent study. This link has also been highlighted by the FDA in a drug safety communication.
Onglyza is one of a class of diabetes type 2 drugs called incretin mimetics which stimulate the release of insulin in order to manage blood sugar. It was approved by the FDA in 2009 and marketed by AstraZeneca in order to tap into the lucrative market for diabetes drugs in the US, where approximately 30 million people have type 2 diabetes. The company has earned hundreds of millions of dollars from the sale of Onglyza and potential earnings have been projected in the billions.
However, an increasing number of these patients have suffered heart failure after taking the drug, with some patients choosing to take legal action.
Onglyza and Kombiglyze XR linked to increased risk of heart failure
In February of 2014, the FDA issued a safety communication outlining concerns about the drug’s connection to heart failure. The safety communication cited a recently published study in the New England Journal of Medicine (known as the “SAVOR study”). The study found a 27 percent increase in risk of heart failure among patients taking Onglyza to treat type 2 diabetes. A second study published in Circulation also found a link between heart failure risks and the medication.
The FDA subsequently determined that an additional warning needed to be added to the Onglyza label informing patients of the increased risk of hospitalization for first time heart failure events. One committee member suggested that the drug be taken off the market entirely, though no recall has been issued.
Some studies have suggested that Onglyza may increase the risk of pancreatic cancer; the FDA did not find sufficient evidence of connection, though they have determined that potential risks are worth further exploration.
Lawsuits allege failure to warn, insufficient testing
Plaintiffs who have filed lawsuits regarding Onglyza and heart failure have argued that AstraZeneca is liable on several counts, including failure to conduct adequate pre-market testing; failure to warn of potential health risks; and fraudulent marketing.
Such plaintiffs filed lawsuits in an attempt to cover losses related to medical expenses, lost wages, or lost earning potential. Other potential losses include loss of consortium and pain and suffering. Families of plaintiffs who have lost lives because of the drug may file a wrongful death lawsuit.
National product liability lawyers at The Sanders Firm are now reviewing potential claims against regarding Kombiglyze XR and Onglyza heart problems. Please call 1-800-FAIR-PLAY to set up a complimentary consultation with one of our attorneys in order to better understand your legal options.
- Reuters, AstraZeneca's diabetes drug Onglyza may increase death rate –FDA http://www.reuters.com/article/2015/04/10/us-astrazeneca-onglyza-fda-idUSKBN0N117620150410#jkm15RZ5rAwMVbIv.97
- Reuters, FDA panel backs safety updates for AstraZeneca, Takeda drugs, http://www.reuters.com/article/2015/04/14/us-astrazeneca-onglyza-fda-idUSKBN0N51U920150414
- FDA, Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA to Review Heart Failure Risk http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385471.htm