From this September 2015 FDA document, “Invokana and Invokamet (canagliflozin): Drug Safety Communication – New Information on Bone Fracture Risk and Decreased Bone Mineral Density”, we learned that there is new evidence about another safety issue with Invokana and Invokamet that has resulted in recent label changes with increased warnings for these popular new diabetes drugs:
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, FDA added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels.
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. Health care professionals and patients are urged to report side effects involving canagliflozin or other SGLT2 inhibitors to the FDA MedWatch program.
We get some background information about these latest safety concerns for Invokana and Invokamet — as well as, possibly, other drugs in the SGLT2 inhibitor class, including dapagliflozin (Farxiga, Xigduo XR) and empaglifozin (Jardiance, Glyxambi, Synjardy) — from this September 2015 news report, “FDA Strengthens Fracture Warning for Canagliflozin”:
The topic of SGLT2 inhibitors and bone was discussed in an article published earlier this year in Lancet Diabetes and Endocrinology by Simeon I. Taylor, MD, professor of medicine at University of Maryland School of Medicine in Baltimore, and colleagues. They explain that SGLT2 inhibitors increase concentrations of phosphate in serum, probably via increased tubular reabsorption, which has the potential to adversely affect bone….
Dr Taylor told Medscape Medical News, “Although not proven, I believe that increased risk of bone fracture is likely a class effect. Nevertheless, individual drugs differ with respect to selectivity for SGLT2 vs SGLT1, and also with respect to where on the dose-response curve the approved dose falls. So, it is certainly possible that the magnitude of the risk could vary among individual SGLT2 inhibitors.”
We will continue to watch for developments regarding increased bone fracture risks for patients using the increasingly popular diabetes drugs Invokana, Jardiance, and Farxiga.[Read this article in full at original source]
Invokana / Farxiga / Jardiance
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