A new analysis conducted by a prominent medical group has linked SGLT2 inhibitors like Invokana to hundreds of reports of metabolic ketoacidosis, also known as diabetic ketoacidosis. This potentially life-threatening condition has already been the subject of two U.S. Food & Drug Administration (FDA) safety alerts.
According to the Institute for Safe Medication Practices latest QuarterWatch report, at least 1.1 million prescriptions had been written for Invokana by the second half of 2015. During the same period, 411,000 prescriptions had been written for Farxiga and 136,000 for Jardiance.
“Despite the lack of long-term data on safety and benefits, these new drugs have moved rapidly into widespread clinical use, according to data from IMS Health,” the ISMP report notes.
As of the 12 months ending June 30, 2015, 168 adverse event reports were submitted to the FDA involving metabolic ketoacidosis and Invokana, while 80 were associated with Farxiga, and 12 involved Jardiance.
Introduced in 2013, Invokana was the first SGLT2 inhibitor approved by the FDA to treat Type 2 diabetes. In addition to Farxiga and Jardiance, other drugs in this class include Invokamet, Xigduo XR and Glyxambi. These medications lower blood sugar levels by preventing the absorption of glucose by the kidneys, thereby facilitating its elimination via urine. As the ISMP points out, the drugs’ association with metabolic ketoacidosis was the greatest safety concern not understood prior to their approval.
In March 2015, the FDA disclosed that it was investigating a number of reports of diabetic ketoacidosis that had occurred in patients using Invokana and other SGLT2 inhibitors. In December, the agency announced that that information about ketoacidosis would be added to the “Warnings and Precautions” sections of all SGLT2 inhibitor labels. The drug’ manufacturers were also directed to conduct a 5-year study in order to analyze post-marketing reports of ketoacidosis in patients treated with SGLT2 inhibitors.
Since the FDA announced its investigation, several Invokana lawsuits have been filed in U.S. courts on behalf of individuals who allegedly developed ketoacidosis while using the medication to treat Type 2 diabetes. In November, for example, a woman who was hospitalized for the condition while using Invokana filed suit in California federal court accusing Johnson & Johnson and its Janssen Pharmaceuticals unit of failing to adequately warn physicians about the risks associated with the medication and the monitoring required to ensure their patients’ safety.