The new wonder drug Invokana® was controversial from the inception. The drug was approved in March 2013 by a vote of 10 to 5 of the FDA Endocrinologic and Metabolic Drugs Advisory Committee with panel members expressing concern over the risk of kidney damage, heart attack and stroke associated with the drug. In addition, some members of the panel were concerned about the “small volume of data” to support use of the product. Invokana®is manufactured by Janssen Pharmaceuticals a subsidiary of Johnson & Johnson.
Invokana is a new drug but the manufacturer Janssen never demonstrated that it is superior to more affordable older drugs such as metformin. Invokana is novel because it works by inhibiting a normal kidney function, which is to return glucose to the blood and discard other undesirable substances. Instead, the drug increases the amount of undesirable sugar in the urine. In the first year of adverse event reporting data, serious injuries to kidney function were reported this according to Quarterly Weekly.
WHAT ARE THE SIDE EFFECTS AND PROBLEMS WITH INVOKANA?
Unfortunately, there are some serious problems associated with the use of Invokana®. Four serious health issues are:
• KIDNEY DAMAGE – has been associated with the drug.
• HEART ATTACK – has been associated with the drug. When the FDA approved Invokana® they required the manufacturer to study the association of between the drug and heart attacks. The study is a 4 year study know as CANVAS which should be concluded in 2017.
• KETOACIDOSIS – has been diagnosed with the drug and can be life threatening. It occurs when ketones increase in a person’s blood or urine. The Food & Drug Administration (FDA) has issued warnings about this condition in May, 2015 and December, 2015
• AMPUTATIONS–On May 18, 2016, the FDA issued a safety announcement alerting the public and physicians about clinical trial results that found an increased risk of leg and foot amputations, mostly affecting toes, with the diabetic medicine Invokana® and Invokamet®. The amputations occurred about twice as often in patients treated with Invokana compared to patients treated with placebo.
Invokana is an early stage lawsuit where the primary claim will involve the failure to warn, strict product liability, overzealous marketing and a failure to adequately study whether Invokana® is any better than less costly drugs on the market. In most defective drug lawsuits the failure to warn claim may be the most important claim for a victim of an alleged defective drug. However, Invokana lawsuits the most interesting claim may involve whether the benefits outweigh the risks. A clear benefit would be a reduction in the strokes or heart attacks. At the time of approval, Invokana had not been tested in a sufficient number of patients to answer the question of whether it is safe and more effective that older well tested products.
As in all pharmaceutical lawsuits, Invokana cases will in all likelihood mushroom into mass tort litigation where there will be consolidation of thousands of individual claims for pre-trial with remand to individual trial courts for trial. Multidistrict litigation is an effective process because it allows victims to pool information, share costs of the litigation yet retain their individual cases for trial purposes. Presently, no MDL has been created for Invokana.
If you or a loved has been injured from using Invokana contact us we would like to help. Click the question mark symbol below or call.
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