FDA removes black box warning from J&J drug

Aug. 26, 2020

The FDA has dropped the dreaded black box warning from Johnson and Johnson’s diabetes drug, Invokana.

The agency originally required the warning due to concerns about an increased risk of leg and foot amputations linked to the drug. But new clinical trial data showed that, when the treatment is closely monitored, the risk is not as high as the FDA had concluded. 

Invokana, a sodium glucose co-transporter 2 inhibitor (SGLT2i), was approved in 2017 to help lower blood sugar in patients with type 2 diabetes and is meant to be used in combination with diet and exercise. Last month, Invokana also received an extended indication for diabetic kidney diseases in type 2 diabetes patients in the EU. The drug raked in $790 million in sales last year.

Despite losing the black box warning, Invokana was recently flagged by researched for posing a potential toxicity risk when paired with the statin Crestor. In one documented occurrence, a patient taking both medications was found to have levels of Crestor in her system 15 times higher than expected, leading researchers to conclude that the combination should be closely monitored in case Invokana puts patients at a higher risk of statin toxicities.

Read the full Reuters report.