Johnson & Johnson continues to face a growing number of legal claims involving Invokana (canagliflozin), a Type 2 diabetes treatment manufactured by its Janssen Pharmaceuticals subsidiary.
According to Johnson & Johnson’s 3rd quarter earnings statement, at least 1,100 Invokana lawsuits have been filed in court’s nationwide as of October 1, 2017.
The majority of these claims have been filed in the multidistrict litigation currently underway in the U.S. District Court, District of New Jersey. Cases have also been filed in state courts in Pennsylvania, California and New Jersey, while several Invokana action lawsuits are pending in Canada.
Johnson & Johnson also acknowledged that it has established an accrual with respect to the Invokana litigation.
“The number of pending product liability lawsuits continues to increase, and the Company continues to receive information with respect to potential costs and the anticipated number of cases,” the report states.
Approved by the U.S. Food & Drug Administration (FDA) in March 2013, Invokana was the first SGLT2 inhibitor to come to market in the United States.
Invokana and other medications in this class are indicated to lower blood sugar levels in adults with Type 2 diabetes. They achieve this by inhibiting the absorption of glucose by the kidney, causing it to be eliminated from the body via urine. While Invokana and other SGLT2 inhibitors have proven to be effective, the potentially serious complications associated with their use have also resulted in several FDA safety alerts.
In December 2015, for example, the agency announced that the labels for Invokana and other SGLT2 inhibitor drugs would be updated to include information about diabetic ketoacidosis, a potentially life-threatening condition that occurs when toxic acids called ketones accumulate in the blood. If not recognized and treated quickly, diabetic ketoacidosis can progress to diabetic coma and even death.
The prescribing information for Invokana, Invokamet (canagliflozin and metformin), and several other SGLT2 inhibitors was again updated in 2016, after the medications were linked to more than 100 reports of acute kidney injury.
In May of this year, a new Black Box Warning – the strongest possible safety alert – was added to, the labels for Invokana and Invokamet after clinical trial results suggested that canagliflozin was associated with an increased risk of leg and foot amputations.