Invokana Lawsuit: Increased Risk of Leg and Foot Amputations
The FDA recently issued a Black Box Warning for users of diabetes medication, Invokana. The new safety alert states that Invokana has been show to increase the risk of leg, foot, and toe amputations.
The notification is based on final results of clinical trials showing that Invokana users may have a risk that is twice as high as normal. Download White Paper (PDF)
The active ingredient in Invokana and Invokamet is canagliflozin, which belongs to a class of drugs known as sodium-glucose co-transporter-2, or SGLT2 inhibitors. Invokana is the single ingredient drug, while Invokamet combines canagliflozin with metformin.
If you or a loved one have had a leg, foot or toe amputation while taking Invokana, you may be eligible for compensation. For a free legal consultation, please fill out the form.
May 16, 2017 FDA Black Box Warning for Invokana
In May of 2016, the FDA issued the first safety warning regarding Invokana and amputation based on interim analysis of two clinical trials. Both studies have now been concluded and final results confirm that Invokana may double the amputation risk. Based on these final results, the FDA has issued a more severe, “black box warning” for Invokana.
The trials in question are known as CANVAS and CANVAS-R, and were intended to assess Invokana’s long-term effect on the heart, however a risk of leg and foot amputations—occurring about twice as often among those taking Invokana as compared to those taking a placebo—was identified.
The May 16, 2017 black box warning is the most severe type of safety alert that can be issued by the FDA. It follows a prior safety communication issued in May of 2016 but indicates a higher level of concern. It will require that information about Invokana’s risk of amputation be printed at the top of prescribing information, enclosed by a box with a thick, black border.
This is the second black box warning for Invokamet which already has a black box requirement due to metformin, its other ingredient. All products containing metformin are required to have a boxed statement about an increased risk of lactic acidosis. The new information about amputation risk will be added to this black box statement.
The FDA’s information release also recommends that health care practitioners consider other patient information which may add to the increased risk before prescribing Invokana. It states that conditions such as neuropathy, peripheral vascular disease, foot ulcers and prior history of amputation may predispose patients to a need for amputation. Patients should be closely monitored and Invokana discontinued if complications develop.
Patients are encouraged to report development of symptoms such as new pain or tenderness, sores, ulcers, or infections. They should not stop taking Invokana but should contact their health care practitioner.