Despite Severe Warnings Invokana Never Recalled by FDA

Written by admin

Invokana, (canagliflozin) is one of several “new generation” type 2 diabetes drugs known as SGLT2 inhibitors was released by U.S Food and Drugs Administration in the U.S. market in 2013, Although Invokana was approved by the United States Food and Drug Administration the drug is associated with several life-threatening adverse effects including kidney problems, ketoacidosis, coma, heart attack, Foot and Leg Amputation and bone fractures. It is manufactured by Janssen Pharmaceuticals, a division of Johnson & Johnson. Janssen also markets Invokamet, a combination of canagliflozin and metformin. There are thousands of lawsuits has been filed against Janssen Pharmaceuticals alleging that the manufacturers Fails to warn patients of the risks associated with Invokana. The growing numbers of patients who took Invokana medication and develop serious health problems are considering legal action.

The FDA warned about potentially fatal side effects of Invokana. In May of 2013, the FDA released a warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis (DKA), a serious condition where the body produces high levels of blood acids called ketones which is immediately life-threatening and that may require hospitalization. The FDA received about 20 reports of DKA from medical personnel, dating between March 2013 and early June 2014. At present many more DKA episodes have been recognized. According to FDA warning patients should not stop or change their diabetes medicines without first talking to their health care professional. The FDA suggests patients to continue treatment unless they have a known susceptibility to any of canagliflozin’s risk factors. However, until more is known, people will likely continue to be severely harmed by the treatment. People taking canagliflozin are urged to monitor their health closely and watch for DKA.

In May of 2016, FDA has issued a new safety alert that the diabetes drug canagliflozin (Invokana, Invokamet, Janssen) has been associated with increased risk of Foot and Leg Amputation. According to the warning the diabetes drug Invokana has been associated with an increase in leg and foot amputations largely affecting the toes. 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 till then the FDA recommends health care professionals should monitor patients for signs and symptoms cause due to amputation.

In June of 2016, the FDA issued a Drug Safety Communication warning about the increased risk of acute kidney injury linked to the diabetes medication. On October 2015; FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use. More than 100,000 people are affected with Kidney failure in the United States each year. The safety communications from the FDA didn’t stop J&J from pursuing an Invokana approval to treat Type 1 diabetes. Invokana may not be considered a safe or effective treatment option when users are aware that they may face an increased risk of diabetic ketoacidosis, kidney failure or death. 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.

The FDA has taken measures to warn patients. But Invokana still remains on the market. The agency has to take action to protect consumers from dangerous medicines and ban these life threatening drugs from the market. If you or someone you love who was prescribed Invokana and then suffered from ketoacidosis, kidney failure, Heart Attack or Stroke may be eligible to file a personal injury Invokana lawsuit against the drug’s manufacturer. The Drugsclaim Lawyers and Attorneys are investigating claims that Invokana may be linked to kidney failure, cardiovascular complications and bone fractures. In filing personal injury lawsuits, injured patients seek compensation for medical expenses, lost work and pain and suffering, among other damages.

About the author


Leave a Comment