They refuse to give up. Despite the overwhelming evidence that the diabetic drug Invokana causes serious side effects that are the cause of action in an increasing number of lawsuits, drugmaker Janssen Phamaceuticals and its parent company Johnson & Johnson are determined to expand the market for the product.
Last year, Janssen started exploring the possibility of marketing Invokana as a weight loss drug and well as a treatment for Type 1 diabetes (which, despite similarity of outward symptoms, is a completely different disorder from the Type 2 variety). Currently, the drug is being tested for use in patients at risk for heart attacks.
The study is known as the CANaglifozin cardioVascular Assessment Study, or CANVAS. It began in December of 2009 and has involved 4300 test subjects. The company is hoping that Invokana will prove effective in preventing “major adverse cardiovascular events, including CV death, nonfatal myocardial infarction (MI), and nonfatal stroke” – particularly people with poorly-controlled diabetes who also have a history of heart problems. Originally, the study was scheduled to last as much as nine years, but is wrapping up almost three years ahead of schedule.
Invokana received FDA approval for the treatment of Type 2 (adult onset) diabetes in 2013. Known scientifically as a “sodium-glucose co-transporter 2 (SGLT2) inhibitor,” it was hailed as a break-through treatment for diabetics. It works by eliminating excess blood sugar through the urine. The FDA granted its approval despite numerous concerns raised by prominent members of the medical community.
Over the next two years, the FDA received over 100 adverse event reports from patients who had suffered serious kidney damage as a result of taking Invokana. In addition to kidney injuries and chronic kidney disease, Invokana has also been strongly implicated in the development of dangerously high acid levels in the blood (ketoacidosis) and osteoporosis. Additionally, the drug has drawn scrutiny from the FDA’s counterpart, the European Medicines Agency, because some of the data from the CANVAS study showed an increase in lower limb amputations among test subjects.
One reason that Janssen Pharmaceuticals is looking to expand the market for Invokana is increased competition from other SGLT-2 inhibitors manufactured by rival companies Eli Lilly (Jardiance) and Boehringer Ingelheim (Farxiga), neither of which are associated with the same risks or carry the same warnings. Additionally, Jardiance has already been shown to prevent stroke and heart attack.
In the meantime, doctors continue to prescribe Invokana, which still enjoys robust sales – even if those sales are flagging. Diabetic patients are strongly encourages to be careful if their doctors do prescribe Invokana for managing their condition. Heart patients should also understand that should Invokana be approved for such treatments, they will run the same risk of side effects as those who take it for diabetes.