Invokana (canagliflozin) is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson. Invokana was approved by the FDA in March 2013 as a treatment option for patients with type 2 diabetes and is the first drug in a new class of drugs called sodium glucose cotransporter-2 (SGLT2) inhibitors to be approved by the FDA.

SGLT2 inhibitors lower a person’s blood sugar by causing the body to remove sugar through urine. Although SGLT2 inhibitors seemed to work well initially, the FDA began receiving adverse event reports of SGLT2 inhibitors (including Invokana) causing ketoacidosis. Ketoacidosis is a complication of diabetes that stops your body from being able to produce insulin. Symptoms of ketoacidosis include difficulty breathing, abdominal pain, nausea, and fatigue to name a few. If left untreated, ketoacidosis can be fatal.

From March 2013 through June 2014, the FDA received at least 20 adverse event reports regarding SGLT2 inhibitors, and they received 73 additional reports of ketoacidosis in patients with type 1 or 2 diabetes treated with SGLT2 inhibitors from March 2013 through May 2015. Most of the patients diagnosed with ketoacidosis required hospitalization or visits to the emergency room for treatment.

From March 2013 through October 2014, the FDA also received information about 19 cases of life-threatening blood and kidney infections that started as urinary tract infections from SGLT2 inhibitor use. All of the 19 patients had to be hospitalized and a few of them even had to be sent to an intensive care unit or dialysis to treat kidney failure.

As a result of the many adverse reports the FDA had received, they issued a warning in May of 2015 that medications such as Invokana could increase the risk of ketoacidosis and kidney failure. The FDA revised their warning in December 2015 and required manufacturers of SGLT2 inhibitors to add warnings about the risk that SGLT2 inhibitors could lead to ketoacidosis.

Invokana is one of Johnson and Johnson’s best-selling drugs, making over $278 million in the first 3 months of 2015. Additionally, Invokana’s website shows that over 6 million prescriptions have been written for Invokana and the number continues to grow. which could lead to a large group of plaintiffs. Only one known lawsuit has been filed against Johnson and Johnson at this time, but with over 6 million prescriptions written, the number can grow at any time.