U.S. sales of the top selling type 2 diabetes drug Invokana, made by Johnson & Johnson subsidiary Janssen Pharmaceuticals, dropped by $50 million during the first quarter of 2017, as lawsuits against the drug makers continue to mount over Invokana side effects. Johnson & Johnson and Janssen face more than 230 Invokana lawsuits centralized in federal multidistrict litigation in the U.S. District Court in New Jersey. All pending cases were filed by individuals who claim to have developed kidney damage or ketoacidosis after using the drug. Ketoacidosis is a dangerous condition in which too much acid builds up in the blood.
The lawsuits involve Invokana and its sister diabetes drug Invokamet, which contains the same active ingredient plus metformin. Invokana was approved by the Food and Drug Administration (FDA) in 2013 to treat patients with type 2 diabetes. In 2013, the FDA approved Invokamet for the same indication. Sine then, the drugs have been the subject of numerous FDA Safety Communications.
In September 2015, the FDA announced it would be updating the labels of Invokana and Invokamet to warn of potential bone fractures and bone mineral density loss. In December of that year, Invokana and other drugs in its class, called SGLT2 inhibitors, were hit with new warnings for diabetic ketoacidosis as well as serious urinary tract infections. In May 2016, the FDA announced it was investigating whether use of Invokana or Invokamet was tied to an increased risk of lower limb amputations. Then in June 2016, the FDA warned that Invokana and Invokamet, along with SGLT2 inhibitors Farxiga and Xigduo XR, were associated with dozens of reports of acute kidney injury.
The first bellwether trials involving Invokana side effects are scheduled for September 2018 and could provide insight into how juries might decide similar lawsuits in the future.
Source: Mass Tort Nexus