Invokana is the brand name for the drug canagliflozin, which was originally developed by Mitsubishi Tanabe Pharma and is currently marketed under license by Janssen Pharmaceuticals, a division of Johnson & Johnson. Invokana was approved by the United States Food and Drug Administration (FDA) in March of 2013 which consequently resulted in the drugmakers directly marketing to both consumers and physicians reaching billions of dollars in profits annually.
Invokana was developed in order to combat type 2 diabetes falling under the classification of a sodium-glucose cotransporter 2 (SGLT2) inhibitor. To do this, Invokana boosts the levels of glucose that leave your body through urination and block the kidneys from reabsorbing the glucose in order to help the body discharge excess sugar. Particularly, in a person with type 2 diabetes, the blood flow intake to the kidneys contains abnormally high levels of sugar, which over time can cause serious issues within the body and to the individual’s organs. The primary goal for Invokana is to have less sugar in the body over time in order to help reduce any potential complications and serious health issues that come with type 2 diabetes.
Is Invokana Dangerous?While there are potential short term benefits to taking Invokana, the drugmaker has been forced over five times to update and change their label in order to accommodate the growing list of issues and symptoms facing Invokana users such as kidney damage, kidney failure, ketoacidosis, and an increased risk of limb amputations.
Two particular studies, CANVAS and CANVAS-R have been used to help highlight Invokana’s potential side effects. Under the original CANVAS study, the risk of amputation for an individual taking Invokana was 5.9 per every 1,000 compared to 2.8 per every 1,000 patients treated with the placebo. Further, under the CANVAS-R study, those numbers were adjusted to 7.5 out of every 1,000 patients taking Invokana compared to 4.2 out of every 1,000 patients on the placebo.
What About the Warnings?The FDA has attempted to mitigate the influx of damage to consumers by the makers of Invokana by way of warning consumers before they use the drug. Between the span of just two years, the FDA has required the drugmaker to update the warning label for Invokana numerous times to help warn consumers of kidney damage, kidney failure, diabetic ketoacidosis, and increased risk of limb amputations. Consequently, in May of 2017 the FDA produced its strongest and strictest possible warning for the drug by use of a ‘black box’ warning. This type of warning is only used when there is a reasonable amount of hazardous and dangerous evidence associated with the specific drug.
A drug company can be held liable for a dangerous drug such as Invokana if it is found that the drugmaker has failed to adequately warn consumers of known dangers or if they should have known of the dangers. This type of allegation is known as a ‘failure to warn’ allegation. Drug companies are required by law to list side effects and continue to keep the public updated after clinical trials as the drug stays on the market over time. However, if a danger is discovered, the drug company may risk losing value either by stock price or by their drug being removed from the market. Negative results could directly impact their financial well-being, creating incentive to hide such negative side effects. While this isn’t across the board, this may be the reason why some companies choose to update their label after it has been on the market for some time rather than conduct the proper testing before it enters.
Do I Have a Case Against the Makers of Invokana?More than 1,000 cases have been filed in state and federal court against Johnson & Johnson and Janssen Pharmaceutical with allegations of failure to warn about kidney failure, heightened amputation risks, ketoacidosis, and more. These cases have been consolidated into multidistrict litigation under the United States District Court of New Jersey. The first bellwether trial is set to begin in September 2018.
Although each case presents a different scenario with varying facts, you should speak with an attorney at Jeffrey Glassman Injury Lawyers who specializes in this area of the law if you or a loved one have taken Invokana and are suffering or have suffered from the symptoms listed above. You may be entitled to significant amounts of compensation in an effort to help put back together what you have lost.
Please contact Jeffrey Glassman Injury Lawyers for a free and confidential consultation to discuss your rights. (617) 777-7777.