FDA demands new warnings for J&J diabetes drug over amputation risk

pharmafile | May 17, 2017 | News story | Manufacturing and Production, Research and Development, Sales and Marketing |  J&J, JJ, Johnson & Johnson, diabetes 

Johnson & Johnson has found itself in deep water again over the potentially harmful effects of its products. This time it has found itself the target of FDA scrutiny, as the organisation is now requiring the company to add new precautionary labelling to its diabetes treatment Invokana (canagliflozin), warning users of the risk of foot and leg amputations associated with its use.

The extent of these amputations most commonly involves the severance of the toe and middle of the foot, but could extend to below or even above the knee.

Invokana is a SGLT-2 inhibitor, a new kind of diabetes drug which operates by reducing blood sugar levels through urine.

The necessity of such a warning stems from the results of two clinical trials which showed that these amputations were twice as likely to occur in those who were treated with Invokana compared to those treated with placebo over the course of one year of treatment. This equates to a risk of 0.59% of Invokana patients compared to 0.28% of placebo users in the first trial, and 0.75% to 0.42% in the second.

Amputation is not the only risk posed by severe type 2 diabetes, and blindness, heart disease and nerve and kidney damage can also occur.

Matt Fellows