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FDA Warns of Fracture Risk with Invokana and Invokamet


Washington, DC: The 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. To address these safety concerns, the FDA has added a new warning and precaution and revised the adverse reactions section of the Invokana and Invokamet drug labels.

The FDA issued a statement noting it 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.

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. 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. Bone mineral density relates to the strength of a person' bones.



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INVOKANA AND INVOKAMET SIDE EFFECTS LEGAL ARTICLES AND INTERVIEWS

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Trenton, NJ: The pleasant-looking man looks into the camera and tells us that taking Invokana “may also help you lose a little weight.” Big problem. The FDA has not approved Invokana for weight-loss. The drug has had a rocky history since its approval in 2013, and a recent FDA warning cites the danger of Invokana leg and foot amputations. Direct-to-consumer drug advertising can magnify the harm that dangerous drugs do to patients who may spend more time listening to that friendly man (or his commercial kin) than they do talking with their own doctors READ MORE

Invokana Lawsuits Consolidated into MDL in New Jersey
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Trenton, NJ: The FDA warns of fracture risk with Invokana and Invokamet and more recently of a higher risk for foot and leg amputation. The lawsuit chickens have now come home to roost READ MORE

Are Risk of Invokana and Invokamet Bone Fractures a Sign of Fractured Regulations?
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August 8, 2017
Washington, DC: A drug indicated for the treatment of type 2 diabetes already carries warnings for compelling adverse reactions including a heightened risk for lower limb amputations, kidney failure, diabetic ketoacidosis and cardiovascular injuries. To that end, the FDA warns of fracture risk with Invokana and Invokamet. Yet in spite of such serious side effects associated with Invokana (canagliflozin) and Invokamet (canagliflozin and metformin), the US Food and Drug Administration (FDA) approved, last year an expanded indication for Invokamet READ MORE
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READER COMMENTS

Posted by
Rochelle bennett
on
I have taken Medformin 500 mg and have suffered with acidosis, cardiovascular several times, the last time, my doctor lied and said b I was in for bronchitis, I have never, never had bronchitis, but have suffered hypoxia (no oxygen). Kidney probably and liver didn't break it down I was always in pain at night. My mom Elaine Williams was on Medformin in 1000 mg, suffers kidney prob, tirdness, bone problems, she has no email.

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