Invokana (canagliflozin) is a prescription medication for people with type 2 diabetes. The drug, combined with proper diet and exercise, is supposed to help with the management of blood sugar levels.
Though Invokana has helped some patients get their disease under control, others have suffered severe side effects.
The most recent concern about Invokana is its ability to increase the risk for needed amputations in users. And most recently, there is evidence that amputation could be needed even in patients who have no prior amputation risk factors.
Clinical Trial Finds Elevated Risk for Invokana Users
Following at least one clinical trial that showed an increased risk for amputation in Invokana users, the US Food and Drug Administration (FDA) issued a safety alert in May 2016. The alert was intended to inform the medical community and current and potential users of Invokana they would face an increased risk for toe, foot, and leg amputations when taking the medication.
The FDA based its alert on information from the Canagliflozin Cardiovascular Assessment Study (CANVAS), which determined the risk for amputation to be about two times as high in Invokana users. The study followed subjects for four and a half years, and determined higher doses of the drug were linked to a need for amputation.
As a result of data gathered from this study, the FDA is now requiring new warnings, including their most prominent Boxed Warning, be added to Invokana labels to alert patients and describe their risk.
Those familiar with the study data point out it did not establish a causative link between the drug and the need for amputation. Users are encouraged not to stop taking the drug without their doctor’s approval. However, if they experience any of the following symptoms, they should seek immediate medical attention:
The latest data from the FDA’s adverse-event reporting system proves the updated label requirements are necessary. Out of 66 reports of type 2 diabetes medication-related amputations, 57 (86%) involved canagliflozin, which in many cases was Invokana. Somewhat surprisingly, two-thirds of those who were forced to undergo amputation were among people with no discernible risk factors.
Amputation Linked to Type 2 Diabetes
According to data from the Centers for Disease Control and Prevention (CDC), nearly two-thirds of all incidences of lower limb amputations are related to type 2 diabetes. This equates to about 80,000 type 2-related amputations per year in the United States.
In addition to use of Invokana, type 2 diabetes patients can also face an increased risk for amputation if they have had the disease for more than a decade, are older, are male, have high blood pressure, live alone, and have other co-occurring health conditions.
Doctors are also encouraged to consider all risk factors for patients before prescribing the medication. These factors include prior amputation, peripheral vascular disease, neuropathy, and diabetic ulcers affecting the foot or other extremities.
Keep in mind, based on the most recent data, Invokana users who show no other signs of problems prior to using the drug could still face an increase in risk when using Invokana.
Invokana Users at Risk
Medications are prescribed to improve a patient’s health and quality of life. Nobody should be forced to worry about serious health complications, especially ones that are unexpected, when they are simply following their doctor’s instructions.
If you or a loved one was forced to undergo amputation after using the type 2 diabetes medication Invokana, you might be entitled to financial compensation. If you would like information or you are ready to speak to someone about your situation, contact our office for more information.