Drug Information Update – New Drug Safety Communication on Invokana (canagliflozin) and Invokamet (canagliflozin and metformin)

Drug Information Update - New Drug Safety Communication on Invokana
(canagliflozin) and Invokamet (canagliflozin and metformin)
FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER's focal point for public
inquiries. We serve the public by providing information on human drug
products and drug product regulation by FDA.


The U.S. Food and Drug Administration (FDA) has strengthened the warning
for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet)
related to the increased risk of bone fractures and added new
information about decreased bone mineral density. Bone mineral density
relates to the strength of a person’s bones. To address these safety
concerns, we added a new /Warning and Precaution/ and revised the
/Adverse Reactions/ section of the Invokana and Invokamet drug labels.

Health care professionals should consider factors that contribute to
fracture risk prior to starting patients on canagliflozin. Patients
should talk to their health care professionals about factors that may
increase their risk for bone fracture. Patients should not stop or
change their diabetes medicines without first talking to their health
care professional.

Canagliflozin is a prescription medicine used with diet and exercise to
lower blood sugar in adults with type 2 diabetes. It belongs to a class
of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors.
Untreated, type 2 diabetes can lead to serious problems, including
blindness, nerve and kidney damage, and heart disease. Canagliflozin
lowers blood sugar by causing the kidneys to remove sugar from the body
through the urine. It 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.

Information about the risk of bone fractures was already in the /Adverse
Reactions/ section of the drug label at the time of canagliflozin’s
approval. Based on updated information about bone fractures from several
clinical trials, we revised the drug label and added a new /Warning and
Precaution/. The additional data confirm the finding that fractures
occur more frequently with canagliflozin than placebo, which is an
inactive treatment. Fractures can occur as early as 12 weeks after
starting the drug. In the clinical trials, when trauma occurred prior to
a fracture, it was usually minor, such as falling from no more than
standing height.

In addition, we have added new information about the risk of decreased
bone mineral density to the canagliflozin label. A clinical trial that
we required the manufacturer of canagliflozin to conduct evaluated
changes to bone mineral density over two years in 714 elderly
individuals and showed that canagliflozin caused greater loss of bone
mineral density at the hip and lower spine than a placebo. This new
safety information has been added to the /Adverse Reactions/ section of
the drug label.

For more information, please visit: Canagliflozin