Regulatory Focus™ > News Articles > FDA: Some Type 2 Diabetes Drugs May Increase Risk of Heart Failure

FDA: Some Type 2 Diabetes Drugs May Increase Risk of Heart Failure

Posted 05 April 2016 | By Zachary Brennan 

FDA: Some Type 2 Diabetes Drugs May Increase Risk of Heart Failure

The US Food and Drug Administration (FDA) on Tuesday updated its safety communication for Type 2 diabetes medicines containing saxagliptin and alogliptin as they may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.

FDA has added new warnings to the following drug labels about this safety issue:

  • 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)

Takeda and AstraZeneca told Focus that they are aware of the label changes.

The decision to update the labels was based on the evaluation of two large clinical trials conducted in patients with heart disease that were discussed at FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meeting last April.

“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,” FDA said. “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. This is the same as 35 out of every 1,000 patients compared to 28 out of every 1,000 patients. Risk factors included a history of heart failure or kidney impairment. In the alogliptin trial, 3.9% of alogliptin-treated patients were hospitalized for heart failure versus 3.3% in the placebo group. This is the same as 39 out of every 1,000 patients compared to 33 out of every 1,000 patients.”

The agency is asking health professionals and patients to report side effects involving saxagliptin and alogliptin, or any other medicines, to the FDA MedWatch program. A previous safety communication was issued on 11 February 2014.

FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin


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