When the FDA made the decision to give Johnson & Johnson’s diabetes drug Invokana a black box warning in 2017, one would like to believe that the decision was not made lightly. The boxed warning is the strongest warning the agency can issue for a drug on the US healthcare market and indicates that the product can pose grave risks to the consumer if used. There is no next warning for a product with a black box on its label; the only thing the agency can do that carries more weight is to force a safety recall.
The boxed warning was issued for Invokana over concerns that the drug could cause an enhanced risk of foot and leg amputation – the very outcome many diabetics fear most and a major motivator for remaining compliant in their treatment. In addition to enhanced amputation risk, the drug has been shown to be responsible for the onset of a condition known as diabetic ketoacidosis which develops when the patient’s body begins producing too much acid in the blood. The condition can be fatal if left untreated.
Patients taking Invokana and other drugs like it known as SGLT2 inhibitors have also been shown to be at enhanced risks of amputations, bone fractures, circumcision, and potentially fatal flesh-eating genital infections. It is a serious drug that can carry very serious consequences.
In a surprising reversal, the FDA removed Invokana’s boxed warning late last month citing recent trials that indicate the risk of amputation is actually less than what they’d previously thought. Additionally, the FDA asserts the new trials indicate Invokana use can actually carry benefits for the patient’s heart and kidneys.
Invokana sales plummeted 20% in the time following the addition of the boxed warning to its label and cost Johnson & Johnson over three quarters of a billion dollars. The FDA’s statement on the removal of the warning carried no indication of who conducted the studies that led to the decision, nor did it state who paid for them.