Posted: January 9, 2018
Invokana (or Invokamet or Invokamet XR), is associated with an elevated risk of amputation of the leg, foot and toes. In fact, the FDA has updated the warnings on these medications to reflect the risk. These medications are sodium-glucose cotransporter 2 (SGLT2) inhibitors, drugs used to treat Type II diabetes.
If you have already had to undergo amputation after taking Invokana, please call our skilled and compassionate attorneys. With more than three decades of experience, we are prepared to pursue justice and compensation on your behalf. For a free legal consultation, please call Eisbrouch Marsh in New Jersey, at 201-342-5545, or in New York, at 212-643-0044.
Increased Risk of Amputation
As someone who has been prescribed Invokana, you probably already know that it treats Type II diabetes by lowering blood sugar. It does so by prompting the kidneys to eliminate sugar through urination. When combined with diet and exercise, these drugs have been effective for many people. But a pair of clinical trials were the first to unveil the increased risk of amputation.
When the trial results were still preliminary, in May, 2016, the FDA released a new safety warning. But once the results were finalized, the FDA stepped up this warning. In May, 2017, the agency required a black box warning for Invokana, which means the risk of amputation is now featured prominently on packaging and labels.
You should never stop taking a medication without first talking to your healthcare provider. The updated warnings mean you and your doctor will have to be vigilant about any new symptoms you develop while taking the drug.
This is not the first time SLGT2s, including Invokana, have been linked to serious complications. The drugs are also associated with a heightened risk of ketoacidosis, in which high levels of acids can lead to kidney failure, coma and death.
What Did the Clinical Trials Show?
The trials, knowns as the CANVAS and the CANVAS-R, showed that the risk of leg and foot amputation was about double for people taking canagliflozin (the ingredient in Invokana) compared to the people taking a placebo.
In the CANVAS trial, over a year the risk of amputation was 5.9 out of every 1,000 patients treated with canagliflozin versus 2.8 out of every 1,000 patients treated with a placebo. In the CANVAS-R, over a year the risk of amputation was 7.5 out of every 1,000 patients treated with canagliflozin versus 4.2 out of every 1,000 patients treated with a placebo.
If you take this drug, do not stop taking it before speaking to your doctor. If you develop any of the following symptoms, report them to your doctor right away:
- New pain or tenderness
- Foot and/or leg infections
You can read the entire FDA safety announcement here.
When to Contact our Attorneys
If you have had an amputation while taking Invokana or another form of canagliflozin, you should call our experienced attorneys for a free legal consultation. We have over 30 years of experience holding drug manufacturers accountable for defective drugs and failure to warn. You may be entitled to compensation. To learn more, please call Eisbrouch Marsh in New Jersey, at 201-342-5545, or in New York, at 212-643-0044. We proudly serve Hackensack, Newark, Manhattan, New York City and all of the surrounding region.