Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is accused of failing to warn about the risk of ketoacidosis with its type 2 diabetes drug Invokana. Diabetic ketoacidosis is a serious condition caused by the build up of ketone bodies, leading to acidic blood levels. It can result in a diabetic coma and even death. According to the lawsuit, Invokana caused diabetic ketoacidosis in a Florida woman who began taking the drug in August 2014. She alleges that the company failed to disclose the risks and asserts that she would not have taken the drug if she were adequately informed.
The lawsuit also accuses Janssen of omitting important safety information from the U.S. Food and Drug Administration (FDA). The plaintiff says that instead of warning the public, the company conducted nation-wide marketing campaigns to promote the drug.
Type 2 diabetes occurs when the body no longer responds to insulin, which allows cells to take up glucose (sugar) for energy. As a result, the cell is starved and the body begins to break down fat instead. When the body breaks down fat for energy, it produces ketone bodies, making the blood more acidic. Diabetic ketoacidosis can occur when diabetes is left untreated, mostly occurring in patients with type 1 diabetes and rarely in type 2. Patients suffering from ketoacidosis may experience difficulty breathing, nausea, vomiting, abdominal pain, confusion, unusual fatigue and sleepiness.
In May 2015, the U.S. Food and Drug Administration (FDA) warned about the risk of ketoacidosis with sodium-glucose cotransporter-2 (SGLT2) inhibitors. The warning included canagliflozin (Invokana manufactured by Johnson & Johnson), dapagliflozin (Farxiga manufactured by AstraZeneca), and empagliflozin (Jardiance manufactured by Lilly/Boehringer). It also included three combination products that include an SGLT2 inhibitor: canagliflozin plus metformin (Invokamet by Johnson & Johnson), dapagliflozin plus metformin extended release (Xigduo XR by AstraZeneca), and empagliflozin plus linagliptin (Glyxambi by Lilly/Boehringer).
The FDA noted that DKA is rare in patients with type 2 diabetes. Based on a search of the agency’s Adverse Event Reporting System database, there were 20 cases of diabetic ketoacidosis related to SGLT2 inhibitors from March 2013 to June 6, 2014.