Two men have filed lawsuits in the Superior Court of New Jersey Law Division in Middlesex County against Johnson & Johnson unit Janssen Pharmaceuticals alleging the company’s type 2 diabetes drug Invokana caused them to have their legs amputated.
Robert E. Shook, 60, of Alabama claims that he had to undergo below-knee, left foot and left leg amputations after taking Invokana. Michael A. Wilkinson, 53, of Iowa, alleges he had to undergo right leg and below-knee amputations after using the drug. Both men have since stopped taking Invokana.
The lawsuits claim that Janssen failed to warn doctors and patients that Invokana put users at an increased risk of lower limb amputations. In May 2017, the Food and Drug Administration (FDA) issued a Safety Communication warning of an increased risk of leg and foot amputations in people treated with Invokana, and announced the agency was requiring its strongest warning – a boxed warning – be added to the labels of the drug.
The warning is based on the FDA’s review of data from two large clinical trials. One study found that 5.9 out of every 1,000 patients treated with Invokana underwent amputations compared to 2.8 out of every 1,000 patients treated with placebo. The second study found that 7.5 out of every 1,000 patients treated with Invokana underwent amputations compared to 4.2 out of every 1,000 in patients treated with a placebo.
Invokana was approved by the FDA in 2013 for the treatment of type 2 diabetes. The drug has been one of the top selling drugs with sales of $1.31 billion in 2015 and $1.41 billion in 2016.