When the Food and Drug Administration (FDA) announced in March 2017 that it was requiring Johnson & Johnson and its subsidiary Janssen Pharmaceuticals to add a boxed warning – the strongest warning required by the FDA – to the labels of its type 2 diabetes medication Invokana regarding an increased risk of amputations in users, some doctors and hospital-affiliated medical groups rushed to take patients off the drug. Amputation is already a risk for diabetics. Why worsen the odds?
The FDA Safety Communication informed consumers that leg and foot amputations occurred about twice as often in patients taking Invokana than in those treated with a placebo. Amputations of the toe and middle of the foot were the most common, but some reports involved the leg, below and above the knee. Some patients had more than one amputation, and some involved both limbs.
Johnson & Johnson has made big profits with Invokana since it was approved in 2013. But sales are slowing. Overall, Johnson & Johnson’s pharmaceutical segment rose 19.4 percent to $9.84 billion, with domestic sales increasing 9.9 percent to $5.35 billion. But sales of Invokana declined 12.7 percent last quarter, which the company blamed on higher managed care discounting.
But the company is also facing more than a thousand lawsuits in state and federal courts over Invokana side effects, including amputations, kidney injury, and ketoacidosis, a serious condition that occurs when too much acid builds up in the blood. Most of the lawsuits have been consolidated into a multidistrict litigation centralized in the U.S. District Court of New Jersey, with the first bellwether trial set for September 2018.
In February 2014, shortly after Invokana was approved, Public Citizen’s Health Research Group designated Invokana as a “do-not-use” drug because it “has not been shown to offer any unique clinical benefits in comparison to several older, safe diabetes drugs. Yet it does pose serious risks that outweigh any of its benefits.”
FDA Safety Communication