The label on Ivokana, a prescription drug used for the treatment of Type II diabetes, will get updated labeling information to include an increased risk of fractures and new information about decreased bone mineral density.
Ivokana (canagliflozin) became the first sodium-glucose co-transporter 2 (SGL2) inhibitor in 2013. In 2014, Ivokamet, a combination of canagliflozin and metformin, was approved by the FDA. These drugs are prescribed by doctors in conjunction with exercise and a healthy diet to reduce sugar levels in adults with Type II diabetes.
After recent clinical trials confirmed evidence that these drugs were linked to an increased risk of bone fracture, the agency updated the labeling. Fractures can occur as early as 12 weeks after use. While a separate trial found patients taking this medication or two or more years suffered losses in bone mineral density in their lower spines and hips. This information was also added to the label.
The newest, strengthened warnings are in addition to an FDA warning in May in which the agency said Ivokana had the potential to cause ketoacidosis, a condition where dangerous levels of toxic acids accumulate in the blood. And, if not treated properly, can prove fatal.
At this time the FDA is unable to determine if these same risks apply to other SLGT2 medications including Farxiga among others. It will continue to monitor them as well and update their labels as needed.
Steve is the Managing Shareholder of Steven J. Klearman & Associates, a civil litigation law firm located in Reno, Nevada. He practices primarily in the areas of civil litigation and injury law, and has authored one of the definitive guides to Nevada civil law that is widely used by Nevada judges and attorneys, his book entitled Elements of Nevada Legal Theories.