Product News and Recalls

FDA Updates SGLT2 Inhibitor Labels, Strengthens Bone Fracture Warnings

sglt2 inhibitors get stronger warnings regarding bone fracturesThe U.S. Food and Drug Administration (FDA) has released a safety alert for Invokana and Invokamet, two drugs in a new line of diabetes medications called sodium-glucose cotransporter-2 (SGLT2) inhibitors. The agency has strengthened warnings about the increased risk of bone fractures associated with the drugs and added information about loss of bone mineral density. Both Invokana (canaglifolozin) and Invokamet (canagliflozin and metformin) use Janssen Pharmaceutical’s SGLT2 inhibitor formula.

According to the FDA, the new data demonstrate that bone fractures occur more frequently in patients using Invokana and Invokamet than those taking a placebo. Fractures were observed as early as 12 weeks after the start of treatment, and were often caused by minimally traumatic events, such as falling from standing height.

SGLT2 inhibitors have been on the market only two years, but already the new class of type 2 diabetes drugs has attracted a great deal of attention. Once concern is SGLT2 inhibitors’ link to diabetic ketoacidosis, a potentially life-threatening blood condition caused by too many ketones, in the blood. In May of this year, the FDA issued a safety communication warning that SGLT2 inhibitors like Invokana, Jardiance, and Farxiga may lead to diabetic ketoacidosis.

In addition, some studies and medical reports suggest SGLT2 inhibitors can make it more difficult for health care workers to detect ketoacidosis in diabetic patients, leading to incorrect or delayed treatment.

Another concern is that SGLT2 inhibitors may cause kidney failure. Although Invokana carries a caution about using the drug with people who have impaired kidney function, there is evidence to suggest that those with normal kidneys may also be at higher risk of kidney injury.

To further educate consumers about the bone fracture and bone density risk, the FDA is including new information about the rate of fractures and decreased bone mineral density that has been associated with Invokana. The information draws from a clinical trial requested by the FDA. The trial evaluated the bone mineral density in 714 elderly patients over the course of two years. Results of the trial revealed that Invokana “caused greater loss of bone mineral density at the hip and lower spine than a placebo.”

The FDA is currently investigating whether other SGLT2 inhibitors, such as AstraZeneca’s Farxiga (dapagliflozin) and Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin), pose similar bone fracture and bone-loss risks.

Speak to your doctor about any health concerns you may have. If you or someone you know was diagnosed with diabetic ketoacidosis or suffered a bone fracture after using an SGLT2 inhibitor, contact the lawyers at Lopez McHugh today to receive a free legal consultation. You may be entitled to compensation through an SGLT2 inhibitor lawsuit.