The FDA’s warning in May came one month after the European Medicines Agency and the UK’s Medicine and Healthcare Products Regulatory Agency sent warnings to healthcare professionals about Invokana’s tie to increased amputations. The warnings were issued after clinical trial results from the Canagliflozin Cardiovascular Assessment (CANVAS) study showed a two-fold increase in risk for lower limb amputations among Invokana users.
According to the CANVAS study, early trial results showed a 46% elevated risk for stroke within the first month of treatment. Based on these results, the FDA demanded that the drug’s manufacturer, Johnson & Johnson, conduct more studies. Those studies yielded the troubling results for increased amputation risk.
The CANVAS trial involved 4,300 Type 2 diabetes patients randomly given 100 mg or 300 mg of Invokana or a placebo. The trial showed that the group receiving Invokana experienced 16 amputation events versus 12 amputation events in the placebo group. After a year of study, it was discovered that seven out of 1,000 patients on 100 mg of Invokana and five out of 1,000 patients on 300 mg of Invokana had a risk of amputation.
Invokana is classified as a SGLT2 inhibitor. It works by passing excess sugar out of the body through urine. Invokana was approved by the FDA in 2013 and in May 2015, the FDA warned that the drug could cause an acid buildup in the blood called ketoacidosis, a potentially fatal condition. In December 2015, the FDA announced that Invokana could also lead to kidney injury and blood infections.
J&J subsidiary Janssen Pharmaceuticals markets Invokana and reported sales of $1.3 billion for the drug in 2015.
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