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FDA Safety Reports & Invokana lawsuit update

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The U.S. Food and Drug Administration (FDA) has announced the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines including J&J’s Invokana/Invokamet (Canagliflozin) and Farxiga/Xigduo XR in June this year. According to the agency they have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimise this Invokana risk. The FDA approved canagliflozin in March 2013, since then the agency received 101 reports of acute kidney injury 73 caused by Invokana and 28 by Farxiga. In these cases, approximately half of the patients experienced acute renal injury within 1 month of beginning the medication. The FDA advised the doctors to carefully consider the factors that may affect patients to the kidney problems before prescribing the drugs. The FDA suggested patients not to stop or change their diabetes medicines without first talking to their health care professional.

Invokana is the latest medication to fall under the scrutiny of the FDA. Invokana (canagliflozin) is one of several “new generation” type 2 diabetes drugs known as SGLT2 inhibitors and also available in combination form with the antidiabetic, metformin, sold under the brand name Invokamet. The drug inhibits normal kidney function to allow patients to pass excess blood glucose through urination. Invokana medication uses with diet and exercise to lower blood sugar in adults with type two diabetes. In last year May the U.S. Food and Drug Administration has issued a warning about the risk of ketoacidosis that may occur after taking the antidiabetic medication, Invokana. Diabetic ketoacidosis (DKA) is a serious condition that can lead to diabetic coma (passing out for a long time) or even death. Plaintiffs from all over the nation filed lawsuits against the manufacturer (Janssen Pharmaceuticals) alleging that there is a link between Invokana and diabetic ketoacidosis and the manufacturers have failed to warn patients and doctors about the life threatening risk associated with the diabetic medicine.

In December 2015, the FDA released another safety communication and warned the drug can also lead to blood infections and UTIs. UTIs cause pain and discomfort, and they can be dangerous if they spread to the kidney. The agency stated that manufacturers of SGLT2 medications, including Invokana, have been mandatory to include additional ketoacidosis and urinary tract warnings on prescribing information and labeling of the medications and as per the agency it is compulsory for the manufacturers to conduct additional post-marketing studies over a 5-year period, regarding the increased risk and long-term safety of the medications. As of yet, the FDA advises 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 discuss with their doctor about the benefits and risks of the drug.

Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, are facing hundreds of Invokana lawsuits due to serious injury caused by Invokana. The plaintiff’s claims that manufacturers 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 drug. Due to the increasing number of cases over the diabetes drug Invokana plaintiffs from Philadelphia Court of Common Pleas filed a petition with the court on Sept. 23rd are seeking to consolidate the action at the federal and state court level into a mass tort program. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of Invokana medication. It will help FDA for further investigations as well as in clinical trials.

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 lawsuit against the drug’s manufacturer. The Drugsclaim Lawyers and Attorneys are investigating  invokana claim 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.

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