The oral diabetes drug Onglyza (saxagliptin), manufactured jointly by AstraZeneca and Bristol-Myers Squibb, is used to control blood sugar levels. Onglyza works by regulating the insulin levels that your body produces after eating. Onglyza received the Food and Drug Administration (FDA) approval on July 31, 2009. In 2011, it quickly became the top selling drug with more than $700 million in sales. Information about pancreatitis was added to Onglyza’s warnings and precautions in 2011. Pancreatitis is an inflammation of the pancreas, and in serious cases, requires hospitalization and can lead to death. Pancreatitis can also lead to pancreatic cancer. A 2013 study showed that medications that act in a similar fashion to Onglyza may be linked to a higher than normal risk of pancreatic cancer. Pancreatic cancer is difficult to treat because often it is not diagnosed until later stages. The FDA panel voted in April 2015 to require AstraZeneca to place a warning on the Onglyza labels which would caution patients of a possible increased risk of heart failure. This decision came after reviewing the data from the SAVOR study, which involved 16,492 patients, 1,222 of whom reported a major cardiovascular event. Of the 15 panelists, 14 voted in favor of placing a warning on the Onglyza labels, while one panel member voted withdraw Onglyza from the United States market altogether.
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