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Patients Taking Invokana and Invokamet Face Increased Risk

Sep 15, 2015

Diabetes patients taking the drugs Invokana and Invokamet (canagliflozin) face increased bone fracture risk, the Food and Drug Administration (FDA) warned in a recent safety communication issued last week.

The FDA has strengthened the warning labels for the type 2 diabetes medication canagliflozin (Invokana, Invokamet) because of the increased risk of bone fractures. The agency has also added information about decreased bone mineral density. Bone mineral density relates to the strength of a person’s bones. To address these safety concerns, the FDA added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet labels.

The FDA is continuing to evaluate the risk of bone fractures with other drugs in the SGLT-2 inhibitor class, including Farxiga and Xigduo (dapagliflozin), and Jardiance, Glyxambi, and Synjardy (empaglifozin) to determine if additional label changes or studies are needed.

Canagliflozin is a prescription medicine used along 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 (SGLT-2) inhibitors. Canagliflozin is available as a single-ingredient product under the brand name Invokana and in a combination medicine with metformin under the brand name Invokamet.

The FDA recommends that health care professionals consider the factors that contribute to fracture risk prior to prescribing canagliflozin. Patients should discuss with their health care professionals factors that may increase their risk for bone fractures, but the agency cautions that patients should not stop or change any diabetes medicine without first discussing this with a health care professional. The FDA reminds patients that when diabetes is not treated, it can result in serious health consequences including blindness, nerve and kidney damage, and heart disease.

The FDA says the safety announcement comes because bone fractures have been seen in patients taking canagliflozin. Fractures can occur as early as 12 weeks after the patient started taking the medicine, according to the safety announcement. Canagliflozin has also been linked to decreases in bone mineral density of the hip and lower spine. The FDA encourages health care professionals and patients are urged to report side effects involving canagliflozin or other SGLT-2 inhibitors to the FDA MedWatch program: Reports may be made online, by mail, or by fax (1-800-FDA-0178).

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