Since its 2013 approval, the U.S. Food & Drug Administration’s (FDA) adverse event data base has received dozens of reports regarding the use of Invokana and kidney failure. The agency has also received numerous reports linking drugs like Invokana to diabetic ketoacidosis (DK), a dangerous condition that can lead to kidney failure and other serious health consequences.
Individuals who have allegedly experienced Invokana-induced kidney failure due to diabetic ketoacidosis may be entitled to compensation for any damages they incurred due to this complication, including payment for medical bills and lost wages. If you would like to learn more about your legal rights, please contact Bernstein Liebhard LLP today to arrange for a complimentary legal consultation with one of our attorneys.
Invokana (canagliflozin) was approved by the FDA in March 2013, and was the first among a new class of Type 2 diabetes medications known as sodium-glucose co-transporter-2 (SGLT-2) inhibitors to be cleared by the agency. But even before it was granted regulatory approval, Invokana was the subject of some controversy. In fact, five out of 15 FDA advisors who reviewed Invokana clinical trial information prior to its launch recommended that the agency not approve the drug, with some reviewers expressing concern about its effects on the kidneys. Once Invokana came on the market, its label did state that the drug should not be used to treat people with pre-existing kidney problems or those undergoing dialysis.
In May 2015, the Institute for Safe Medication Practices (ISMP) disclosed that the FDA had received 457 adverse event reports for Invokana in the first 12 months it was on the market. Of these, 54 involved cases of kidney failure or renal impairment. “The unanswered question about canagliflozin—shared in part by other diabetes medications—is whether it has clinical benefits, and whether those benefits outweigh its risks,” the ISMP wrote.
The same month the ISMP issued its report, the FDA announced that it was reviewing the safety of all SGLT2 inhibitors for a possible association with diabetic ketoacidosis (DKA), a dangerous condition caused by the accumulation of toxic ketones (acid) in the blood. According to the FDA, it had received 20 reports of acidosis (reported as diabetic ketoacidosis (DKA), ketosis or ketoacidosis) among SGLT2 patients between March 2013 and January 6, 2014. Ketoacidosis is a potentially life-threatening condition that can result in kidney failure, diabetic coma and even death.
If you developed kidney failure as a result of Invokana-induced ketoacidosis, the attorneys at Bernstein Liebhard LLP are here to help. To learn more about filing an Invokana lawsuit, please call to schedule a free, no-obligation legal review.