Johnson & Johnson subsidiary Janssen Pharmaceuticals is being sued by a Texas man who claims the company’s type 2 diabetes drug Invokana caused him to develop ketoacidosis, a potentially life-threatening condition in which too much acid builds up in the blood.
Arthur Portnoff, who filed his lawsuit in Philadelphia Court of Common Pleas, claims he began taking the drug in November 2014 and was hospitalized in February 2015 with ketoacidosis. He claims that Janssen knew the drug could cause serious injuries but failed to adequately warn patients or doctors of this risk.
His complaint also states that Janssen did not conduct enough studies to be assured of the drug’s safety, and that the company withheld information from drug regulators about the drug’s risks.
Earlier this month, the Food and Drug Administration (FDA) ordered stronger warnings added to the label of Invokana and other drugs in the class to include the risk of urinary tract infections and blood problems including ketoacidosis.
The agency said that reports of ketoacidosis in type 2 diabetics taking Invokana and similar drugs was unusual as the condition is generally seen in type 1 diabetics. Ketoacidosis is a disorder in which too much acid, known as ketones, build up in the blood. It causes symptoms such as nausea, vomiting, abdominal pain, tiredness and breathing problems. If left untreated, it can be fatal.
Earlier this year, the FDA ordered Janssen to strengthen warnings on Invokana and Invokamet to include new information about decreased bone density and increased risk of bone fractures.
Invokana contains the active drug ingredient canagliflozin. Invokamet contains canagliflozin plus the diabetes drug metformin. Both are approved to treat people with type 2 diabetes.