Beerse, Belgium-based Janssen Pharmaceutical’s top-selling diabetes drug Invokana (canagliflozin) continued to come under scrutiny in April and May with new lawsuits filed, along with questioning from the European Medicines Agency (EMA) about serious potential adverse effects.
Lawsuits in the US and Canada allege that patients weren’t warned about serious risks, including diabetic ketoacidosis, of the drug, a sodium-glucose cotransporter-2 (SGLT2). In addition, the EMA’s Pharmacovigilance Risk Assessment Committee has asked Janssen for more information about whether Invokana triggered a spike in lower-limb amputations. An ongoing clinical trial of about 4000 patients with type 2 diabetes treated daily with either 100 mg or 300 mg of Invokana or a placebo has so far shown higher rates of lower limb amputation in the Invokana groups.
The Food and Drug Administration in 2015 strengthened Invokana’s label warning to include information about an increased risk of bone fractures associated with use of the drug.