Compliance Management

FDA Panel Backs Heart Failure Warning for AstraZeneca, Takeda Diabetes Drugs

Apr 14, 2015


A U.S. FDA advisory committee said that AstraZeneca's diabetes drug Onglyza and Takeda Pharmaceutical's rival product Nesina should carry information about the risk of heart failure.

According to Reuters, data showed a statistically significant increase in the risk of heart failure with Onglyza and an increased risk with Nesina that did not reach statistical significance. However, the panel found that neither Onglyza nor Nesina increased the risk of cardiovascular death, stroke or heart attack.

The studies were requested by the FDA as part of a broader investigation into the safety of diabetes drugs.

Read the Reuters press release