US FDA panel favors new safety information on AstraZeneca’s Onglyza

April 16, 2015 12:33 PM

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US FDA panel favors new safety information on AstraZeneca’s Onglyza

The cardiovascular safety profile of AstraZeneca’s diabetes drug Onglyza is acceptable, but its label should carry information about the potential increased risk of heart failure, US regulatory advisors have concluded.

Heart failure “seems like a real signal, but I think it’s occurring in a setting where we can more or less predict the people who would be at risk, ” Morris Schambelan, a panel member and professor emeritus of medicine at the University of California at San Francisco, said during the discussion on O...

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