The U.S. Food and Drug Administration have issued a new safety warning to the public on May 18th. According to the warning the diabetes drug Invokana has been associated with an increase in leg and foot amputations largely affecting the toes. The agency is reviewing the risk of foot and leg amputation cause due to Invokana Medication. The alert comes after improvised safety results from a constant, ongoing “CANVAS” clinical trial. According to the Clinical Trial Invokana medications cause Higher Risk of Amputation to the patients. The FDA in its warning stated that it is continuing to figure out the new information and will provide more advice to the public once it is available. The FDA recommends health care professionals should monitor patients for signs and symptoms cause due to amputation.
Invokana (canagliflozin) is one of several “new generation” type 2 diabetes drugs known as SGLT2 inhibitors approved on March 29, 2013 by U.S Food and Drugs Administration. The drug inhibits normal kidney function to allow patients to pass excess blood glucose through urination. It is manufactured by Janssen Pharmaceuticals, a division of Johnson & Johnson. Janssen also markets Invokamet, a combination of canagliflozin and metformin. As per the ongoing “CANVAS” clinical trial the drug increases the risk of Foot and Leg Amputation. According to the Canagliflozin Cardiovascular Assessment Study, the amputations occur approximately twice as often in patients taking Invokana as compared with those who took a placebo.
What is Foot and Leg Amputation?
Although Invokana was approved by the United States Food and Drug Administration at the end of March in 2013 it associated with several life threatening complications. Recently FDA announced the link between Invokana medication and increase risk of Foot and Leg Amputation. Blood vessel and nerve damage linked with diabetes can lead to serious infections that are extremely hard to treat that lead to removal of a leg, foot or toes from the body that is called Leg or foot amputation. These body parts are called extremities. According to the CANVAS ongoing clinical trial the incidence of lower limb amputation is 7 per 1000 patient-years in the canagliflozin 100 mg group and 5 per 1000 patient-years in the canagliflozin 300 mg group, compared with 3 per 1000 patient-years who were given a placebo.
Symptoms of Foot Complications
- Infections spread rapidly
- Skin becomes black
- Injuries hard to heal
- Cold skin
- Chronic pain
Patients should not stop or change their diabetes medicines without first talking to their health care professional. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Healthcare professionals and patients are encouraged to report adverse events or Invokana side effects. It will help FDA for further investigations as well as in clinical trials.
Invokana Amputation Lawsuits
Invokana has been linked to kidney problems, ketoacidosis, coma, and heart attack .In a series of new Invokana lawsuits according to plaintiffs Invokana link with increase risk of Foot and Leg Amputation, the drug’s manufacturer Janssen Pharmaceuticals, a subsidiary of corporate giant Johnson & Johnson, actively defended its product and failed to provide adequate warnings and communications to the medical community and end line consumers of the increased risk of serious and life threatening medical complications associated with these drugs.
Any patient who was prescribed Invokana and suffered from Foot and Leg Amputation contact Drugsclaim .The Drugsclaim Invokana Lawyers and Invokana Attorneys are investigating claims that Invokana may be linked to kidney failure, cardiovascular complications, Foot and Leg Amputation and bone fractures. We have an experience team of Invokana injury lawyers to handle and evaluate the claim. They are prepared to help you and your family gets the compensation you deserve and that is free of cost till we win your case.