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Invokana® (canagliflozin) is a prescription medication used for the treatment of Type 2 diabetes. Although it is taken by many diabetics across the country, Invokana has been associated with serious and life-threatening side effects, including dehydration, diabetic ketoacidosis, kidney failure, heart attack, and more. Additionally, the results of a new study of over 10,000 patients found that Invokana doubles the risk of toe, foot, and leg amputations in patients with Type 2 diabetes.
If you or someone you love has suffered adverse health effects after taking Invokana – including the need for amputation – you may have the right to pursue legal action and recover financial compensation for your damages, including your pain and suffering, medical expenses, and more. Spangenberg Shibley & Liber LLP is currently reviewing cases from patients nationwide who suffered harm after taking Invokana – and we are readily available to help you learn more about your rights and legal options.
Discuss your case during a FREE consultation. Call (216) 600-0114.
Amputation Risks & Side Effects of Invokana
Invokana is a prescription medicine that can help lower blood sugar in adult patients with Type 2 diabetes. Possible side effects disclosed by the drug’s manufacturer, Janssen Pharmaceuticals, include dehydration, yeast infection, urinary tract infections, and changes in urinary habits.
However, various studies have found that more serious side effects may be caused by this drug that were not disclosed to patients. These include several new studies that prompted the FDA to issue a drug safety communication associating Invokana with increased risks of toe, foot, and leg amputations.
The FDA warning, issued in May 2017, is based on the results of two large Phase III prospective, double-blind, randomized studies (considered the gold standard in epidemiology) performed by Janssen. Those studies showed a doubling of the risk of amputation for patients taking Invokana. Results of the studies – CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (CANVAS-Renal) – were published in the New England Journal of Medicine.
- There were a total of 10,142 participants in the two studies. Out of 5,790 patients in the Invokana group, 140 patients needed amputations (2.42%). Only 47 of 4,344 patients in the placebo group needed amputations (1.1%).
- The study analyzed the statistics in patient years and found that Invokana patients had a statistically significant increased risk of amputation (6.3 vs. 3.4 participants per 1000 patient-years).
- The hazard ratio was 1.97 (95%CI, 1.41-2.75) in total.
- For patients with a history of peripheral vascular disease, the hazard ratio was 2.34 (95% CI, 1.53-3.58).
- Some patients had more than one amputation. There were 221 amputations total in the Invokana group and only 69 total in the placebo group. This likely represents patients with multiple toes being amputated.
- Out of 140 patients with amputations in the Invokana group, roughly 54% (76) had toe amputations; 16.3% (23) had mid-foot amputations; .6% (1) had an amputation at the ankle; 18% (26) had below-the-knee amputations; and 10% (14) had above-the-knee amputations.
How Invokana Increases Risks of Amputations
The kidneys naturally remove sugar from the blood, but the sugar is then immediately reabsorbed back into the blood. Invokana works by preventing the reabsorption of sugar back into the blood, resulting in sugar being passed through the kidneys and excreted through the urine. This causes patients on Invokana to urinate more frequently and expel more fluid than normal. When a person gets dehydrated, blood vessels must constrict to maintain blood pressure.
Because many diabetic patients have poor blood flow, and tend to have more wounds on their feet due to diabetic neuropathy, a supply of fresh blood to the lower extremities is critical for the healing of wounds. When patients are on Invokana and become dehydrated, the constriction of the blood vessels leads to worse blood flow in the legs, feet, and toes, and can significantly increase the risk of amputations in diabetic patients.
In a sense, Invokana takes a kink in a hose and makes it much worse.
Other Side Effects Associated with Invokana
Additional studies, including one report from the Institute for Safe Medication Practices (ISMP), have associated Invokana with other serious side effects, including:
- Kidney Failure – Invokana has been associated with an increased risk of complete shutdown of the kidneys, which filter waste products from the blood. Properly-functioning kidneys are responsible for regulating blood pressure, red blood cell production, and electrolyte balance. When kidneys shut down, waste products build up and poison the body, causing weakness, abnormal heart rhythms, confusion, lethargy, and sudden death.
- Heart Attack – Use of Invokana has been linked to an increased risk of heart attacks (myocardial infarction) caused by blood being restricted to certain areas of the heart. When these areas are deprived of oxygen, the heart tissue dies, which can be fatal to the patient.
- Ketoacidosis – Ketoacidosis results from the body’s inability to produce a sufficient amount of insulin to regulate blood sugar. When the body lacks enough insulin, it burns fat instead, which results in a high concentration of toxic acids called ketones to build up in the bloodstream.
What You Can Do
If you or a loved one has experienced an amputation or other injury while taking Invokana, please do not hesitate to contact one of our experienced attorneys at Spangenberg Shibley & Liber LLP. We are actively investigating amputation cases involving the use of Invokana, and we would be happy to review your case personally and discuss with you whether you have a valid claim for compensation.
To request a FREE consultation, call (216) 600-0114.