The FDA is alerting consumers that there is an Invokana amputation risk associated with the popular diabetes drug. The FDA is now requiring a black box warning on the label so that consumers are aware of the foot and leg amputation risk.
Following the FDA-mandated CANVAS trial (1), which found that Invokana doubled the risk of lower limb amputations compared with patients taking a placebo, many healthcare providers have decided to stop prescribing the diabetes drug.
The CANVA trials started in 2009. Initially, the trials showed beneficial results that prompted the FDA to approve Invokana in 2013. But, recent studies show that Invokana side effects include more than amputation. They also include the life-altering side effects of kidney damage and diabetic ketoacidosis.
According to the Canva study, half of the amputations observed were of toes, while the remainder included the foot, above the ankle, below the knee and above the knee. Because Invokana is prescribed to people with Type-2 diabetes, patients are already at a higher risk for amputation. The study showed that patients that have already undergone amputation are at a much higher risk of secondary amputation if they are taking Invokana
In mid-May, following the CANVA results, the FDA ordered Invokana to carry a new black-box label warning patients of the increased risks of lower limb amputations. The warning urged patients using Invokana to contact their doctor “right away” if they experience any pain or tenderness, sores, ulcers, or infections in their legs or feet.
Though the author of the CANVA study says that the drug does show success in reducing the risk of cardiovascular events, the newly associated risks of amputation has led healthcare providers to take preemptive measures to avoid future amputation lawsuits brought upon by patients affected by Invokana.
Invokana Amputation Lawsuits
To avoid the threat of amputation lawsuits, doctors have begun to use alternative treatments for Type-2 diabetes patients. Some healthcare providers have also started to substitute prescriptions for current Invokana users. The focus is mostly on patients with predisposed conditions that put them at a higher risk of amputation, such as patients who have previously undergone amputation.
While a number healthcare systems have now taken Invokana off of their list of drug treatments for hospitalized patients, the popularity of the drug still puts many Type-2 diabetes patients at risk. TruLaw urges all patients on Invokana to speak to a healthcare provider about the Invokana amputation risk. Please do not stop taking any medications until you have spoken to your physician or healthcare provider.
It is estimated that 4.5 million Invokana prescriptions were filled in 2016 in the United States, alone. However, it is expected that the FDA’s black box warning will cause a huge decrease in sales of Invokana as the number of prescriptions will decrease significantly as it will likely alarm patients.
There is no indication that manufacturer Janssen — a subsidiary of Johnson & Johnson pharmaceutical — plans on taking the current form of Invokana off the market. Invokana lawsuits are currently being filed on behalf of individuals who were injured while taking Invokana.