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September 10, 2015: Invokana Bone Risks – FDA Strengthens Label Warnings

Invokana Bone Risks – In a Drug Safety Communication dated September 10, 2015, The U.S. Food and Drug Administration (FDA) announced that the warning for the type 2 diabetes drug canagliflozin (Invokana and Invokamet) has been strengthened related to the increased risk of bone fractures, and that new information about decreased bone mineral density has been added to the product labeling.

However, the FDA advised that patients should not stop taking or change their medication stating “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.”

Invokana Bone Fracture Warning – Invokana Bone Risks

Information regarding the risk of bone fracture was included in the “Adverse Reactions” section of the Invokana and Invokamet labeling at the time the drugs were approved. According to the FDA however, bone fracture information obtained from several clinical trials prompted the agency to revise the label by adding bone fracture safety information to the “Warning and Precaution” section of the label. The clinical data confirmed the finding that fractures occur more frequently with Invokana than with placebo. The FDA reported that in the clinical trials, when a trauma happened prior to a bone fracture, it was usually minor, for example, falling from no more than standing height.

Invokana Decreased Bone Mineral Density – Invokana Bone Risks

The FDA also required that new information about the risk of decreased bone mineral density must be added to the “Adverse Reactions” section of the Invokana and Invokamet labels. In a clinical trial that evaluated changes to bone mineral density over two years in 714 elderly individuals, Invokana caused greater loss of bone mineral density at the hip and lower spine than did placebo. This new bone mineral safety information has been added to the Adverse Reactions section of the drug label.

Previous FDA Safety Communication Regarding Invokana And Ketoacidosis

In a Drug Safety Communication dated May 15, 2015, the FDA warned that SGLT2 Inhibitors, including Invokana and Invokamet may lead to a serious medical condition known as ketoacidosis. Ketoacidosis is a condition that occurs when the body produces high levels of blood acids called ketones, and may require hospitalization.

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Canagliflozin (Invokana and Invokamet) Is A SGLT2 Inhibitor

Canagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor. SGLT2 Inhibitors are a class of drugs approved for use with diet and exercise to lower blood sugar levels in adults diagnosed with type 2 diabetes. Invokana lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. Canagliflozin is marketed to patients as single-ingredient medication (Invokana) and also in combination with metformin (Invokamet). SGLT2 inhibitors have not been approved by the FDA for use in type 1 diabetes patients.

FDA Will Continue To Evaluate Bone Risks and SGLT2 Inhibitor Use

The FDA will continue to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapagliflozin (Farxiga, Xigduo XR) and empagliflozin (Jardiance, Glyxambi, Synjardy), to determine if label changes or additional studies to evaluate safety are needed. Health care professionals and patients can report side effects involving canagliflozin (Invokana and Invokaamet) or other SGLT2 inhibitors to the FDA’s safety reporting program at MedWatch.

Contact The Weinberg Law Firm for a Free Invokana Lawsuit Evaluation.

Attorney Eric Weinberg has represented thousands of patients injured by drug adverse events including for example, the products Vioxx, Baycol, Pradaxa, Ortho Evra, and blood clotting products. If you or a loved one suffered a bone fracture or other bone complication after taking Invokana, or you developed ketoacidosis after taking Invokana or Invokamet, please contact our law firm for a free Invokana lawsuit evaluation by calling toll free at 1-877-934-6274. You can also contact us by submitting our easy-to-use legal case evaluation form found on this page.

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