US FDA warns on risks from type 2 diabetes drug canagliflozin
The US Food and Drug Association has reinforced the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet), from Johnson & Johnson (NYSE: JNJ), related to the increased risk of bone fractures, as well as its impact on bone mineral density.
The regulator has added a new warning and precaution and revised the adverse reactions section of the Invokana and Invokamet drug labels.
The FDA is continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapagliflozin (Farxiga, Xigduo XR) and empaglifozin (Jardiance, Glyxambi, Synjardy), to determine if additional label changes or studies are needed. Health care professionals and patients are urged to report side effects involving canagliflozin or other SGLT2 inhibitors to the FDA MedWatch program.
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