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Lawsuit Alleges Janssen Failed to Disclose Risk of Ketoacidosis with Invokana

Aug 4, 2016

A lawsuit has been filed on behalf of a Florida woman who alleges that Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, failed to warn about the risk of ketoacidosis with its Type 2 diabetes medication, Invokana. According to court documents, the plaintiff began take the drug in August 2014 to control high blood sugar resulting from her diabetes. She then suffered diabetic ketoacidosis, which she alleges was caused by the drug.

Patients with Type 2 diabetes have developed resistance to insulin, the hormone responsible for allowing glucose (sugar) into a cell. As a result, excess glucose builds outside the cell while the cell itself is starved for energy. To compensate, the body breaks down fat for energy, creating ketone bodies. High levels of ketones make the blood more acidic, leading to the condition known as ketoacidosis. Diabetic ketoacidosis (DKA) is a condition that occurs when diabetes goes untreated; it can occur in both types of diabetes, but is rare in patients with Type 2. It can lead to a diabetic coma, and perhaps even death.

In May 2015, the U.S. Food and Drug Administration (FDA) warned that sodium-glucose cotransporter-2 (SGLT2) inhibitors used to treat diabetes may lead to ketoacidosis requiring hospitalization. The safety alert 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). According to the FDA alert, there were 20 cases of diabetic ketoacidosis related to SGLT2 inhibitors from March 2013 to June 6, 2014; these cases were identified through a search of the FDA's Adverse Event Reporting System (FAERS) database.

Patients suffering from ketoacidosis may experience difficulty breathing, nausea, vomiting, abdominal pain, confusion, unusual fatigue, and sleepiness.

The recent lawsuit alleges that Janssen failed to warn about the risk of ketoacidosis associated with Invokana. The plaintiff alleges that she would have chosen a different medication if she were adequately warned about all of Invokana’s side effects. Janssen is accused of concealing important safety information from the FDA and conducting nationwide marketing campaigns instead.

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