Most people who get diagnosed with type 2 diabetes don’t assume that amputation is in their future. One recent FAERS analysis reveals diabetics taking Invokana (canagliflozin) are twice as likely to require foot, toe and leg amputations. (Invokana belongs to the SGLT2 inhibitor drug class and helps diabetics regulate their blood sugar.) The results show an increased amputation risk has not emerged in studies for competing SGLT2 inhibitor drugs Farxiga and Jardiance. As a result, the U.S. Food and Drug Administration recently issued an update on Invokana amputation risks. What’s more, Invokana amputation concerns aren’t the only FDA-issued warnings involving SGLT2 inhibitors in recent years. If you or a loved one take Invokana, read on to learn more about the recent FDA update.
FDA Issues Updated Safety Communication About Invokana Amputation Risks
The FDA issued its first Invokana amputation warning in May 2017. This drug safety communication came after two randomized, double-blind clinical trials published their results showing significantly increased Invokana amputation risks. This updated FDA safety statement also required Invokana’s manufacturer, Janssen Pharmaceuticals, to add black box warning labels to its packaging.
New data from the FDA’s adverse-event reporting system (FAERS) only reinforces that initial May 2017 Invokana amputation warning. Researchers compiled and analyzed 66 SGLT2 inhibitor-induced amputation reports from FAERS and published the results in Lancet Diabetes & Endocrinology. Among those, researchers discovered that 57 (86%) were Invokana amputation reports. The remaining side effect cases involved other serious complications, such as diabetic ketoacidosis, kidney failure, heart attacks, strokes and diabetic coma.
Even more startling is the fact that approximately 64% of Invokana amputations occurred in patients with no discernible risk factors. “Worryingly,” said the study’s coauthor, Dr. Gian Paolo Fadini, “[it] points to an unpredictable effect of the drug.” By carefully examining statistical data within this cohort, researchers found that on average, 60-year-old male patients were most at risk. Average treatment duration prior to Invokana amputation was 1.5 years.
Most Invokana patients reporting severe adverse events needed toe amputations. However, 20% were above-ankle leg or limb amputations as well as three fatal cases reported with the 66-patient study group.
Looking Deeper Into the New Invokana Amputation Study Analysis
Because researchers did not find an increased amputation risk Invokana’s competitors Jardiance (empagliflozin) and Farxiga (dapagliflozin), several experts voiced concern. “Our data are the first to confirm the warning (from the FDA)… and tends to suggest this is not a class effect,” Dr. Fadini stated in a Medscape Medical News interview. “We can only reinforce, with independent data, the boxed warning issued by the FDA and call for caution [with] canagliflozin.”
What Invokana Amputation Victims Can Do
Amputation isn’t the only serious health risk that type 2 diabetics taking Invokana need to know about. Other life-threatening Invokana complications include diabetic ketoacidosis (DKA), strokes and kidney disease. Lawsuits are now underway for Invokana amputation victims as well as family members filing wrongful death claims for the deceased. Allegations state that pharmaceutical giant Janssen failed to properly warn patients about serious – even potentially fatal – Invokana side effects. We encourage amputees and others experiencing severe Invokana-related health issues to explore their compensation options with an experienced mass tort attorney immediately.
To see if you may qualify for a cash settlement from the manufacturer, fill out your Invokana evaluation form now. Once you’ve submitted your information, an experienced advocate will contact you to discuss your compensation options and possible next steps. If you’re harmed by a defective medical device or drug, holding pharmaceutical companies accountable for their negligence can help protect other patients in the future.
Related: FDA Warning: Invokana Doubles Diabetic Amputation Risks