FDA Says Diabetes Drug Onglyza May Increase Risk of Death

FDA Says Diabetes Drug Onglyza May Increase Risk of DeathApril 13, 2015 — The type-2 diabetes drug Onglyza showed an increased risk of death in a clinical trial investigating heart risks, according to an analysis by the FDA.

The SAVOR clinical trial involved nearly 16,500 patients with diabetes who also had a high risk of cardiovascular disease. Some were given Onglyza and some were given a placebo.

An FDA analysis suggested that patients on Onglyza (saxagliptin) experienced “significant or near-significant” increases in “all cause mortality.” Patients were also more likely to be hospitalized for heart failure. According to the FDA:

“An increased risk of hospitalization for heart failure was noted in subjects treated with saxagliptin, and FDA sensitivity analyses suggested a potential increased risk of all-cause mortality in saxagliptin- treated subjects.”

The analysis did not say what caused the increased risk of death. According to Bloomberg, it is possible that the baseline characteristics of patients who were sicker and older made solid conclusions difficult.

The FDA has been investigating the heart failure risk associated with Onglyza since 2008. Evidence linking Onglyza and a 27% increased risk of heart failure was published two years ago in the New England Journal of Medicine and led to a Safety Communication from the FDA.

Onglyza belongs to the DPP-4 inhibitor class of drugs, which treat diabetes by mimicking incretin hormones. In addition to concerns about heart failure, studies have suggested a possible increased risk of pancreatitis and pancreatic cancer from drugs in this class.

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