Litigation Over Kombiglyze XR and Onglyza. Potential Lawsuits Over Onglyza and Kombiglyze XR Drugs. Personal injury attorneys are investigating potential lawsuits over Onglyza and Kombiglyze XR, diabetes medications containing saxagliptin.
Drug injury lawyers are reviewing whether or not they can pursue litigation over Kombiglyze XR and Onglyza in light of evidence linking these medications to heart failure, pancreatic cancer and thyroid cancer.
Onglyza and Kombiglyze XR are both used to lower blood sugar, along with diet and exercise, in patients with type 2 diabetes. Onglyza contains saxagliptin as its main active ingredient while Kombiglyze contains both saxagliptin and metformin hydrochloride.
They belong to a class of medications known as incretin mimetics. Incretin mimetics became more popular after Avandia, another type of diabetes drug, was recalled because it was linked to cardiac deaths.
There has been increased attention surrounding the heart risks of diabetes medications following the Avandia recall. In 2013, the New England Journal of Medicine published a study showing that patients who took Onglyza had a slight increased risk of being hospitalized for heart failure compared to patients taking other diabetes drugs. The study, known as SAVOR, was funded by Bristol-Myers Squibb and AstraZeneca.
Concern for Onglyza Medication
The rise in hospitalization for heart failure with Onglyza was not statistically significant. However, the findings were enough to raise concern among experts. In April 2015, the majority of an FDA advisory committee recommended that the label on Onglyza be updated to include information about cardiovascular findings. For Onglyza, panel members wanted the new label to note an increased risk of heart failure and information on all-cause mortality.
In March 2013, a study published in the journal Diabetes linked incretin mimetic drugs to a possible increased risk of pancreatitis and pancreatic cancer. Researchers looked at autopsies of 20 patients with diabetes; 8 had taken an incretin mimetic.
The authors found that incretin mimetic use was associated with a larger pancreas, a 6-fold increase in the number of beta cells in the pancreas and “eccentric” pre-cancerous cell growth and small tumors called adenomas.
A month before the study was published, researchers at Johns Hopkins found that diabetic patients hospitalized with pancreatitis were twice as likely to be taking an incretin mimetic.
In light of these findings, the FDA said it would investigate whether incretin mimetics were associated with pancreatitis and pancreatic cancer.
Since 2009, the FDA has been reviewing the relationship between incretin mimetics and thyroid cancer. The agency published a safety communication in 2011 stating that researchers found a higher rate of malignant thyroid tumors in rodents treated with an incretin mimetic.