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Onglyza was co-formulated by Bristol-Myers Squibb and AstraZeneca in 2007. On July 31, 2009, it was approved by the FDA for treatment of type-2 diabetes. Its key active ingredient, saxagliptin, is a DPP-4 (dipeptidyl peptidase-4) inhibitor. This means it works to prohibit the DPP-4 enzyme from performing its normal function of destroying incretin, which is the hormone responsible for producing insulin and eliminating excess glucose production.

Negative side effects of Onglyza

On April 5, 2016, the FDA issued a warning for type-2 diabetes medications that contain saxagliptin. This safety announcement stated that medications containing saxagliptin lead to an increased risk of heart failure, especially for patients with a history of heart or kidney illnesses. Diabetes medications like Onglyza, which contain saxagliptin, were required to add this warning to their label.

Severe side effects of Onglyza (other than heart failure) can include the following:

  • Low blood sugar
  • Pancreatitis - inflammation of the pancreas
  • Joint pain
  • A rare skin condition (bullous pemphigoid) that causes severe blisters
  • Peripheral edema - fluid retention that leads to swelling of hands, feet, or ankles

Bristol-Myers Squibb and AstraZeneca face over 100 product liability lawsuits

Before Onglyza carried proper warnings on its label, many patients were unknowingly exposed to an increased risk of heart failure. This has led to lawsuits against co-manufacturers Bristol-Myers Squibb and AstraZeneca. Around 100 individual lawsuits from throughout the United States have been consolidated in federal multi-district litigation in the United States District Court for the Eastern District of Kentucky. Other lawsuits also pending in California.

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