Invokana is the first of a new class of diabetes drugs known as sodium-glucose co-transporter 2 inhibitors (SGLT2). Shortly after its release in March of 2013, patients began reporting adverse side effects, including nausea and vomiting. A Georgia woman named Paula Brazil recently filed a lawsuit against Invokana’s manufacturer, Johnson & Johnson, alleging that she developed ketoacidosis after taking the drug. Ketoacidosis is characterized by abnormally high levels of blood acid and can be extremely dangerous, often resulting in hospitalization. The lawsuit claims that Johnson & Johnson and its subsidiary Janssen neglected to adequately warn of Invokana’s potential for causing ketoacidosis. Contact a Boston Drug Injury Lawyer Today.
Failure to Warn
Brazil claims that after beginning treatment with Invokana, she immediately began to experience significant weight loss, nausea, and vomiting. Within two weeks, she was admitted to the hospital and was subsequently diagnosed with ketoacidosis. Invokana is specifically designed to treat type 2 diabetes, a condition that is not typically associated with ketoacidosis. In addition to vomiting and nausea, ketoacidosis also involves symptoms such as confusion, difficulty breathing, fatigue, and abdominal pain, and it typically requires emergency healthcare and/or hospitalization. Brazil’s lawsuit stated that, “Invokana is unreasonably dangerous and defective as formulated, putting consumers, including Plaintiff, at an unreasonable risk of suffering injury and death.” It went on to say that, ““As the developers, manufacturers and distributors of Invokana, Defendants knew or should have known that it was associated with serious complications, including diabetic ketoacidosis.”
FDA Received 457 Adverse Event Reports for Invokana
Brazil’s lawsuit is only the latest in a rising number of lawsuits filed against Invokana’s manufacturer’s in recent weeks. In addition to claims of developing ketoacidosis, several plaintiffs allege they developed kidney failure, kidney stones, urinary tract infections, and other forms of kidney impairment. Following the FDA’s safety warning issued in May 2015, lawsuits have begun to grow rapidly. The warning indicated that reports of high levels of blood acid among Invokana-users was being investigated. The Institute of Safe Medication Practices (ISMP) also released a report evaluating 457 adverse drug event reports, potentially linking Invokana and other SGLT2 drugs with kidney problems in patients. In fact, Invokana receives more adverse event reports than 92% of the drugs monitored by the same group. ISMP’s report addressed the questions of whether the benefits outweigh the risks, and if a recall of Invokana should be issued. Continue reading