Primary Care Corner with Geoffrey Modest MD: FDA broadens indication for empagliflozin to include cardiovascular protection!!!

By Dr. Geoffrey Modest

The FDA just extended the indication for the diabetes drug empagliflozin (Jardiance) to include reducing cardiovascular mortality in those with diabetes and cardiovascular disease. Their press release (see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm531517.htm ) states that they looked at postmarketing data, though their original approval 2 years ago indicated that they requested 5 years of post-marketing data.

See my prior blog critiquing the original study leading to FDA approval ( https://stg-blogs.bmj.com/bmjebmspotlight/2015/12/21/primary-care-corner-with-geoffrey-modest-md-empaglifozin-the-good-and-the-bad/ )