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FDA safety concerns over saxagliptin and alogliptin

The FDA has issued a safety alert regarding saxagliptin (Onglyza®) and alogliptin (Vipidia®). More information is available in the FDA safety announcement. The Summary of Products Characteristics for saxagliptin and alogliptin for the UK market already contain cautionary information about using these medicines in patients with heart failure.

A safety review found that type 2 diabetes medicines containing saxagliptin and alogliptin (including combinations containing metformin) may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. The FDA alert advises that healthcare professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control.

The review included data from two large clinical trials (SAVOR and EXAMINE). In the saxagliptin trial, 3.5% of patients who received the drug were admitted to hospital for heart failure versus 2.8% of patients who received a placebo. In the alogliptin trial, 3.9% of alogliptin treated patients were admitted to hospital for heart failure versus 3.3% in the placebo group. The trials ran for different durations but these data indicate that for approximately 1 in every 150 patients treated with either of these drugs for around 2 years would be expected to be admitted to hospital with heart failure.

Patients taking these medicines should be advised contact a healthcare professional if they develop signs and symptoms of heart failure such as:

Action: Clinicians should be aware of this recent safety development. Patients who are prescribed these medicines should be monitored for signs of heart failure and these medicines stopped should signs develop.