Since its approval in 2013, Invokana and other similar SGLT2 inhibitors that treat Type 2 diabetes have received numerous complaints and injury reports. This data compelled the FDA to strengthen its warning label on these drugs.
“Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk,” the FDA said.
From the time the FDA approved these medications in 2013 to 2015, the agency received 101 reports of acute kidney injury — 73 caused by Invokana and 28 by Farxiga. Of these cases, 96 patients required hospitalization, and 22 of these cases required admission to intensive care. Four patients died while hospitalized. In about 50 percent of these cases, acute kidney injury occurred within one month or less of starting the drug.
According to the FDA, 56 of these patients discontinued the medications and saw some improvement, but it warned that kidney injury is not reversible in all situations. The agency recommended that physicians and healthcare providers should screen patients for factors that might predispose them to kidney injury before prescribing Invokana or Farxiga.
These SGLT2 inhibitors work by passing excess blood sugar out of the body through urine. However, an ongoing investigation of Invokana and similar drugs has shown an increase in leg, foot and toe amputations in people who used the drug. In addition, there is an increased risk of ketoacidosis — a potentially fatal condition caused by excess blood acid. In December 2015, the FDA released another safety communication and warned the drug can also lead to blood infections and kidney injuries. A higher potential for stroke in Invokana users has also been demonstrated in the research.
If you or a loved one have been injured after taking Invokana or a similar SGLT2 inhibitor, please contact us for a free, confidential evaluation.