FDA Strengthens Warning on Invokana Labeling

The U.S. Food and Drug Administration (FDA) recently revised its May 2015 warning to now include an increased risk of bone fractures and decreased bone mineral density. Bone mineral density relates to the strength of a person’s bones.

The original FDA warning stated that SGLT2 inihibitors like Invokana may cause diabetic ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. See our previous post on Inokana injuries and 10 Things Invokana Patients Need to Know. Other friends of our firm have also posted on the dangers of Invokana as well: What is the problem with Invokana? and Public Citizen Calls on FDA to Stop Misleading Invokana Advertisements

What is Invokana?

Invokana (canagliflozin) is a prescription medication designed to be used in combination with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. 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.

Invokana and Bone Fractures

Information about the risk of bone fractures was already included in the Adverse Reactions section of the drug label at the time of canagliflozin’s approval, but based upon updated information about bone fractures from several clinical trials, the drug label was revised to include a new Warning and Precaution. The additional data confirm the finding that fractures occur more frequently with canagliflozin than placebo, and fractures may occur as early as 12 weeks after starting the drug. For more information on the specifics of this issue, see the FDA’s notice: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density.

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. The agency recommends that health care professionals consider factors that contribute to bone fracture risk prior to prescribing canagliflozin to patients, and encourages patients to talk to health care professionals about factors that may increase their risk for bone fracture.

*Invokana is a registered product of Janssen Pharmaceuticals and their other related corporate entities. Their interests are adverse to ours as a law firm representing patients suffering from potentially related injuries.