![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA Beefs Up Warning Labels for Canagliflozin and Dapagliflozin
FDA Beefs Up Warning Labels for Canagliflozin and Dapagliflozin
The FDA is requiring stronger warning labels for Type 2 diabetes drug products that include canagliflozin — such as Invokana and Invokamet — and dapagliflozin — such as Farxiga and Xigduo XR — following reports affirming an increased risk for acute kidney damage.
Updated labeling includes information and factors to consider before taking the drugs to minimize the risk of kidney damage, including:
- Decreased blood volume;
- Chronic kidney insufficiency; and
- Congestive heart failure.
The new warning labels also note that taking diuretics, blood pressure medicines and nonsteroidal anti-inflammatory drugs may increase the risk of kidney damage.
Between March 2013 and October 2015 – when canagliflozin was approved – the agency received reports of 101 cases of AKI, 73 for canagliflozin and 28 for dapaglifozin.
Upcoming Events
-
11Jul
-
18Jul
-
21Oct