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# FDA Requires Heart Warning on Diabetes Drugs
- URL: https://www.fdaweb.com/fda-requires-heart-warning-on-diabetes-drugs/
- Published: 2016-04-05T12:00:00.000Z
- Updated: 2026-09-14T20:52:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135286

> New FDA warnings are being added to Type 2 diabetes medicines containing saxagliptin and alogliptin after an agency safety review found that they may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. The warnings are an extension of a 2014 drug safety communication ([see earlier story](http://www.fdaweb.com/login.php?sa=v&aid=D5127667&searchWords=saxagliptin&cate=S&stid=%241%24bL2.IK3.%245CsQv4bFM3pgWghbgSsK6%2F)), the agency says.  
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> [FDA says](http://www.fda.gov/Drugs/DrugSafety/ucm486096.htm?ref=fdaweb.com) it evaluated two large clinical trials conducted in patients with heart disease. “Each trial showed that more patients who received saxagliptin- or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo,” it says. “In the saxagliptin trial, 3.5% of patients who received the drug were hospitalized for heart failure versus 2.8% of patients who received a placebo... In the alogliptin trial, 3.9% of alogliptin-treated patients were hospitalized for heart failure versus 3.3% in the placebo group.”  
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> The agency recommends that health care professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control. Affected products are: AstraZeneca’s Onglyza (saxagliptin)AstraZeneca’s Kombiglyze XR (saxagliptin and metformin extended release)Takeda’s Nesina (alogliptin)Takeda’s Kazano (alogliptin and metformin)Takeda’s Oseni (alogliptin and pioglitazone)