Data suggests AstraZeneca drug may increase death rate - U.S FDA

(Reuters) - AstraZeneca Plc's (AZN.L) diabetes drug Onglyza appears to be associated with an increased rate of death, according to a review of data published by the U.S. Food and Drug Administration on Friday.

While the primary clinical trial results did not show a statistically significant increase in the rate of death, a more detailed analysis examining only patients who took Onglyza suggests "a significantly increased risk of all-cause mortality," FDA staff said in their review.

The FDA said the causes of death were often "multifactorial" and some patients may have had several serious medical conditions in the days and weeks prior to death. Still, the FDA said it "is not reassured that the observation that causes of death span multiple disparate etiologies, and we do not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance."

(This version filed to add 'Friday' in first paragraph)

(Reporting by Toni Clarke in Washington)