Onglyza Product CasesAnnotate this Case
In 2008, as part of the defendants’ application for approval of Onglyza and Kombiglyze XR, two diabetes drugs with saxagliptin as the active ingredient, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee required that defendant AstraZeneca perform a cardiovascular outcomes study. “SAVOR” was a randomized, double-blind, placebo-controlled study that consisted of 16,492 patients with type 2 diabetes who were at high risk of cardiovascular disease. The study concluded that saxagliptin did not increase or decrease the risk of these occurrences but noted a higher risk of hospitalization. Following SAVOR, the FDA required warning labels for medications containing saxagliptin, referring to the potential increased risk of heart failure. Researchers conducted additional studies and did not find an association between saxagliptin and an increased risk of hospitalization for heart failure.
Patients who took drugs with saxagliptin filed approximately 250 related cases. Most of these cases were filed in federal court and consolidated into federal multidistrict litigation. A Judicial Council coordination proceeding (JCCP) was established for the California state court cases. The court of appeal affirmed summary judgment in favor of the defendants. The court upheld the exclusion of the plaintiffs’ general causation expert, who opined that saxagliptin can cause heart failure.