SILVER SPRING, Md. — The European Medicines Agency is reportedly pressing Johnson & Johnson for answers about whether Invokana has triggered a spike in toe amputations.
A clinical trial, called Canagliflozin Cardiovascular Assessment Study (CANVAS), recently revealed that Invokana patients had twice the risk of toe amputations over patients that received placebos, according to Medscape.
The study has reportedly prompted the EMU’s Pharmacovigilance Risk Assessment Committee to question whether there should be changes to the way the controversial drug is used in Europe.
The study is reportedly tracking approximately 4,000 Type 2 diabetes patients treated with Invokana or a placebo, and has shown higher rates of toe amputation in the Invokana groups.
The risk is a new development, as previous clinical trials indicated a risk, but not one so significant.
“We take all new information on safety seriously and respect and agree with the recommendation of the Independent Data Monitoring Committee to continue the CANVAS study,” Johnson & Johnson’s Janssen unit said in a statement.
Last year, the U.S. Food and Drug Administration ordered Janssen to affix a warning label to Invokana detailing the drug’s connection to increased risk of fracture and losses in bone density.
Invokana Complications, Symptoms
Canagliflozin and other SGLT2 inhibitors are powerful anti-diabetes drugs that prevent the blood from reabsorbing glucose.
The number of low-grade side effects is often considered to be a sign of the drug’s potency, and dry mouths, headaches, abdominal discomfort and other mild or moderate symptoms are often dismissed by the public at large.
But red flags go up when the side effects become serious, as is the case with Invokana. In addition to a loss of bone density, which may be caused by the lack of nutrients in the blood, Invokana has been linked to:
- Diabetic Ketoacidosis: DKA occurs when the body can no longer burn glucose for fuel and must exclusively rely on fat. When this happens, ketones (waste products) build up in the blood and eventually become toxic.
- Blood Infections: These issues begin with kidney infections, and may eventually become life-threatening.
- Stroke: Similar CANVAS trials indicated a 46 percent increase for heart problems in Invokana patients.
Damages in these cases include compensation for economic losses, like hospital bills, noneconomic losses, like pain and suffering, and punitive damages, which are intended to punish the tortfeasor (negligent actor) and deter future wrongdoing.
Our Dangerous Drug Lawyers Can Help
Our dangerous drug attorneys can help if you or someone you care about was injured during or after ingesting Invokana.
Lawsuits have been filed against the drug makers by both patients and their families seeking compensation for injuries caused by the dangerous drug. You may be entitled to a settlement.
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