In the short time that the type 2 diabetes drug Invokana has been on the market, it has been linked to a number of serious side effects including life threatening ketoacidosis and acute kidney injury. But another deadly side effect may soon be unveiled.
Johnson & Johnson’s Janssen Pharmaceuticals is currently conducting five studies investigating the cardiovascular risks associated with of its top-selling drug Invokana. Though no data from the study has been released, red flags have been raised. During clinical trials, 13 patients taking Invokana had a heart attack or stroke, compared to just one on a placebo, during the first 30 days of treatment.
There is much speculation about what Invokana’s heart study might reveal.
Earlier this month, the Food and Drug Administration (FDA) announced it was expanding the indication for a similar diabetes drug Jardiance, to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and cardiovascular disease. It might be easy to assume that other diabetes treatments in the SGLT2 inhibitor class have similar cardiovascular benefits. But early studies on Invokana suggest otherwise.
Invokana was approved by the FDA in 2013, but data ultimately used to clear Invokana also showed “an imbalance in early cardiovascular events,” said FDA reviewer Dr. Hyron Kwon during a committee hearing. FDA Biostatistician Dr. Mat Soukop also testified that in the first 30 days of use, Invokana had a cardiovascular events hazard ratio of 6.9. In other words, people treated with Invokana were 690 times more likely to suffer a heart attack or stroke than patients taking a placebo.
Like other newer diabetes treatments, the FDA required Invokana’s makers to conduct heart studies to assess cardiovascular risk. Those results are expected sometime in 2017. In the meantime, Invokana was given the green like to market in the U.S.
Since Invokana was approved, the FDA has added new or strengthened warning to the drug’s safety label regarding bone mineral density loss, bone fractures, serious urinary tract infections, ketoacidosis, lower limb amputations, and acute kidney injury.