Invokana's boxed warning regarding amputation risk was removed on May 23, 2022 [1]. This action followed a review by the U.S. Food and Drug Administration (FDA) [1].
Why Was the Black Box Warning Lifted?
The FDA's decision to remove the boxed warning was based on the agency's evaluation of post-marketing data. This data indicated that the risk of amputation associated with Invokana (canagliflozin) was not as high as initially perceived when the warning was first issued [1]. The initial warning was implemented in December 2016, following concerns raised by the CANVAS and CANVAS-R clinical trials, which suggested an increased risk of lower-limb amputations in patients with type 2 diabetes treated with canagliflozin [2][3].
What Does This Mean for Patients and Doctors?
With the removal of the boxed warning, Invokana is now marketed without this specific FDA-mandated caution about amputation risk [1]. However, healthcare providers continue to be advised to assess patients for risk factors for amputation, such as peripheral artery disease, neuropathy, and a history of ulcers or amputation, before initiating treatment with canagliflozin [1]. Patients are encouraged to discuss any concerns about this risk with their doctors.
Are There Other Safety Concerns with Invokana?
While the amputation warning was removed, Invokana still carries other potential risks and side effects. These can include urinary tract infections, yeast infections, dehydration, and a rare but serious condition called Fournier's gangrene [4]. Patients should consult the drug's prescribing information and discuss potential side effects with their healthcare providers.
How Does Invokana Work?
Invokana belongs to a class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors [5]. It works by blocking the reabsorption of glucose in the kidneys, which leads to more glucose being removed from the body through urine, thereby lowering blood sugar levels [5]. It is used in conjunction with diet and exercise to improve glycemic control in adults with type 2 diabetes [5].
When Was Invokana First Approved?
Invokana received its initial FDA approval on March 28, 2013 [3].
What Are the Alternatives to Invokana?
For managing type 2 diabetes, other SGLT2 inhibitors are available, such as Jardiance (empagliflozin) and Farxiga (dapagliflozin) [6]. Additionally, various other classes of antidiabetic medications exist, including metformin, DPP-4 inhibitors, GLP-1 receptor agonists, and insulin [7]. The choice of medication depends on individual patient factors, including co-existing conditions, efficacy, safety profile, and cost.
Sources:
[1] https://www.fda.gov/drugs/drug-safety-and-availability/fda-removes-black-box-warning-invokana-canagliflozin-about-lower-limb-amputation-risk
[2] https://www.drugpatentwatch.com/blog/fda-expands-warnings-on-diabetes-drug-invokana
[3] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205040s021lbl.pdf
[4] https://www.invokana.com/
[5] https://www.drugpatentwatch.com/drug/invokana
[6] https://www.drugpatentwatch.com/blog/sglt2-inhibitors-what-you-need-to-know
[7] https://www.drugpatentwatch.com/blog/understanding-diabetes-medications