Considering our government is bought and paid for by Big Pharma, it’s only fitting that Janssen Pharmaceuticals has used the Beltway’s time-honored “Friday news dump” to inform the public that its blockbuster diabetes medication, Invokana, causes kidney injuries when it quietly updated Invokana’s warning label on Friday, May 20, 2016. Invokana is in a class of medications called sodium glucose cotransporter 2 (SGLT2) inhibitors which are intended to treat high blood sugar in type 2 diabetics. As you recall, back in May 2015, the FDA alerted the public to the risk of diabetic ketoacidosis (DKA) associated with SGLT2 inhibitor use, and then required the manufacturers of all drugs in the class to update the warnings section to include DKA in December 2015.
At the time, the FDA’s involvement brought, at least some, media scrutiny to a class of drugs which are designed to flush high quantities of unmetabolized sugar through the kidneys of a population of patients already at risk of kidney-related complications. Unsurprisingly, Janssen’s latest label change (news dump) has been completely ignored by the media, leaving the public under-informed, again.
Nevertheless, Janssen is now expressly warning that acute kidney injuries are associated with using Invokana. In light of the mounting litigation over claims that Invokana causes kidney failure and other kidney injuries, it seems as though Janssen has read the tea leaves, and knows that a label change, whether voluntary or FDA-mandated, was needed. Nevertheless, concerns about the adequacy of the warning label remain, as Invokana has been associated with kidney failure, not just acute kidney injury, as described in Janssen’s newest warning label. In fact, the new label continues to downplay the severity of injury that Invokana users risk.
With over a billion dollars in sales last year, for just Invokana, it’s no wonder Janssen is intent on downplaying the severity of the risks associated with Invokana and keen to keep stories like this limited to the Friday news dump.