In May 2015, the FDA warned that type 2 diabetes drugs like Invokana could have a potentially dangerous side effect: diabetic ketoacidosis (DKA). This is a serious condition in which the blood becomes too acidic, and can lead to complications like dehydration, coma, and even death in severe cases.
In response to this warning and to reports of diabetes patients suffering from this condition, the American Association of Clinical Endocrinologists (AACE) has announced that they will review the potential relationship between DKA and drugs like Invokana “to provide answers to questions from its membership raised in response to recent case reports and publications on the subject.”
Questions About Invokana Side Effects
The FDA approved Invokana for the treatment of type 2 diabetes in March 2013. Part of a class of drugs called “SGLT2 inhibitors,” Invokana works by inhibiting the reabsorption of glucose, causing some of it to be flushed away via the urine. This results in a lower blood glucose level for the patient.
Since its approval, however, Invokana has been subject to questions and concerns about its potential side effects. In addition to the recent FDA warning, it was also singled out in the Institute for Safe Medicine Practice’s (ISMP’s) QuarterWatch report for the second quarter of 2014. In the report, the authors noted that “early signals for a new kind of diabetes drug, canagliflozin (INVOKANA) raise questions about whether enough is known about this agent to be assured that its benefits outweigh its risks.”
At that time, Invokana had been linked with 457 reports of adverse events, including kidney failure or impairment, dehydration and fluid imbalances, kidney stones, and urinary tract infections. Additional concerns came to light when authorities noticed reports of type 2 diabetes patients taking SGLT2 inhibitors and suffering from DKA—an unusual combination, as typically, type 1 diabetes patients are more at risk for the condition.
Medical Group Plans to Review Safety of Invokana
The AACE, which represents more than 6,000 endocrinologists in the U.S. and abroad, plans to hold its scientific and clinical review of DKA and the effects of SGLT2 inhibitors on October 24-25, 2015, in Dallas, Texas. There, the group will assemble top scientists, diabetes experts, and “relevant stakeholders in the diabetes arena” to examine available data and “provide recommendations for prescribers and patients.”
In its drug safety communication about the concern, the FDA stated that “patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.”
They added that SGLT 2 inhibitors work by causing the kidneys to remove glucose from the body through urine, but that a search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of DKA in patients treated with these drugs from March 2013 to June 2014. The administration noted that they’ve continued to receive more of these reports since then.
Patients Taking Invokana Should Speak to their Doctors About Side Effects
The AACE noted that their review is mainly to address unanswered questions on the potential relationship between SGLT2 inhibitors and DKA. Meanwhile, patients who are taking these drugs are advised to speak to their doctors about any potentially serious side effects. Those who have suffered from DKA while taking Invokana may be eligible to file a lawsuit to recover damages.
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