The U.S. Food and Drug Administration is strengthening its warning that the type 2 diabetes drugs Invokana and Invokamet (canagliflozin) can increase the risk of bone fractures. The agency also added new information about decreased bone mineral density in patients who take the drug.

The FDA has added a new warning and precaution and revised the ADVERSE reactions section of the Invokana and Invokamet drug labels.

The agency said it is continuing to evaluate the risk of bone fractures with other drugs in the sodium-glucose cotransporter-2 (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. 

Canagliflozin is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

The FDA provided the following additional information for health care professionals:

  • Bone fractures have been seen in patients taking the type 2 diabetes medicine canagliflozin.
  • Fractures can occur as early as 12 weeks after starting canagliflozin.
  • Canagliflozin has also been linked to decreases in bone mineral density at the hip and lower spine.
  • Consider factors that contribute to fracture risk prior to initiating canagliflozin.
  • Counsel patients about factors that may contribute to bone fracture risk.