A Kentucky woman has filed a lawsuit against Invokana’s manufacturer, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), alleging the company failed to warn her of the risks associated with the drug.
The woman began taking Invokana to treat her diabetes in February 2015. Shortly after she began taking the medication, she suffered a serious and life-threatening stroke. The woman asserts that if she had known Invokana increased her risk of suffering a stroke, she would not have taken the medication.
When Invokana was approved in 2013, several cardiologists on the review committee expressed concern about the drug’s cardiological safety. The FDA granted approval with the condition that Janssen and Johnson & Johnson (J&J) were to conduct postmarketing studies on the drug to determine if it presents any dangers to the cardiovascular system.
One of the ongoing postmarket studies, called CANVAS, showed Invokana increased a patient’s risk of suffering a stroke by 46% within the first 30 days of treatment. Unfortunately for Invokana patients, strokes aren’t the only serious side effect associated with the drug.
Just last month, the FDA issued a safety communication strengthening its prior warnings regarding Invokana. Recent reports have shown Invokana can also cause chronic kidney disease and kidney failure. Within two years after the drug’s approval, the FDA received more than 100 reports of kidney injury caused by Invokana. Nearly half of kidney injuries reported occurred within 30 days of starting the medication.
But the trouble with Invokana doesn’t end there. Clinical trial results have shown that Invokana also increases the likelihood of amputations in patients by nearly double. This prompted the European Medicines Agency to advise doctors to consider prescribing safer alternatives of Invokana to patients.
Lawsuits over the safety of Invokana are quickly taking shape, but it will still take some time before any cases reach trial. Plaintiffs in the litigation are nonetheless determined to see their day in court with Invokana’s manufacturers.