Last week the FDA increased their warning of the increased risk between bone fractures and type 2 diabetes medications, Invokana and the combo drug Invokamet. They have revised the drug’s labels adding information about decreased bone density and the risk of hip and lumbar spine fractures. Fractures have been reported as early as 12 weeks after beginning treatment.
The FDA had already listed bone fractures as a possible side effect. However, after reviewing the results of a 2 year postmarketing study of 714 elderly patients with type 2 diabetes, they concluded that drugs containing canagliflozin, an SGLT2 inhibitor contained in Invokana and Invokamet carried a serious risk of fractures. The FDA is still evaluating whether to order studies or increase warnings on other SGCLT2 diabetes drugs such as Farxiga and Jardiance.
Approved in 2013, Invokana and Invokamet have performed well for drug manufacturer, Janssen Pharmaceuticals, Inc. earning top dollars in a highly competitive marketplace. Unfortunately, Invokana has received 2 FDA warnings in the short time it has been sold in the US.
The first FDA warning, issued in May 2015, was due to the risk of ketoacidosis, high levels of blood acids called ketones. This serious condition may require hospitalization and could lead to kidney damage. Symptoms of ketoacidosis include fatigue, confusion, abdominal pain and vomiting. Lawsuits are being investigated for patients that took Invokana and were then diagnosed with ketoacidosis.
The second FDA warning about the risk of bone fractures, which was issued just last week, raises a red flag about the safety of this type 2 diabetes medication. Could this drug be linked to patients experiencing bone density loss and broken bones?
We urge anyone that has taken a prescribed medication and then experienced a serious side effect to contact us. You may have a valid financial claim against the drug manufacturer.
The FDA has been concerned about the safety of Invokana since it was approved 2 years ago. If you are currently taking this medication, do not stop before discussing options with your medical professional. If you have taken Invokana and were treated for ketoacidosis, you may qualify for compensation.
Since the first FDA warning, our firm has been evaluating lawsuits on behalf of diabetics that took the medication and were later diagnosed with ketoacidosis. Now with the second FDA warning, we are investigating whether patients whose broken bones may be a result of treatment with Invokana may have grounds for a legal claim.