More patients than ever have come forward to report to their physicians, and the FDA’s adverse event reporting system, about problems with Invokana dangers.
Invokana dangers may include the risk of amputation, requiring a patient who is taking this critical diabetes medication to lose a limb.
Invokana dangers have led to the implementation of a black box warning associated with the amputation risks.
This SGLT-2 drug has been in use for years for those with Type-2 diabetes and it is often prescribed off-label for those who have Type-1 diabetes.
FDA Warning Now Required on Invokana About Amputation Risk
The FDA now requires that Invokana dangers be clearly explained on a black box warning to advise patients about the serious risk of amputation.
Clinical trials recently identified that foot and leg amputations occurred approximately twice as often in those taking Canagliflozin; a drug present in products, Invokamet, Invokamet XR and Invokana.
The amputation risk for those patients inside the clinical trial over the course of a year was equal to approximately six out of every 1,000 patients taking Canagliflozin and 2.8 out of every 1,000 patients using a placebo medication.
Clinical Trials Reveal Amputation Possibility for Invokana Users
The most common amputations associated with Invokana include toe and foot amputations. However, above and below the knee leg amputations were also observed in the clinical trial.
Certain patients who were at high risk of Invokana dangers experienced amputation of multiple limbs.
In 2015, the warning associated with Invokana dangers was strengthened associated with the possible danger of bones fractures and the label had also been updated to reflect a higher risk of acute kidney injury.
Anyone who develops new sores, ulcers, tenderness, pain or infections in the feet or legs should immediately contact their physician about the risk of Invokana dangers and how this should be pursued.
A physician may recommend that the medication be stopped entirely. Other Invokana dangers include problems reported by other patients, such as bones breaks, low blood pressure, ketoacidosis, yeast infections, increased cholesterol, a high level of potassium in the blood, low blood sugar and serious urinary tract infections.
Invokana dangers associated with amputation may be very serious in nature in light of the fact that the amputation risk may increase so quickly that the person has to very suddenly undergo surgery.
Anyone who has already found themselves in this position of suffering from the devastating side effects of Invokana dangers and who believes that they were never properly warned by the manufacturer about these risks may be eligible to file a lawsuit.
Many lawsuits filed by patients in similar situations allege that the company is responsible for failing to warn consumers and the medical community about the problems with Invokana.
If you’ve sustained injuries because of Invokana side effects, consult with the experienced lawyers at McDonald Worley to find out about your next steps.