Last month, the FDA made news when it announced new warnings about ketoacidosis and urinary tract infections would be added to three diabetes drugs of the SGLT2 class: Invokana, Jardiance and Farxiga.
Now, DrugNews reports that an increasing number of former Invokana patients are filing lawsuits against the maker of the drug, Janssen, after being subjected to ketoacidosis with little or no prior warning from the manufacturer.
Lawsuits recently surfaced in California and Pennsylvania, although lawyers expect the rising numbers could lead to the creation of a dedicated federal court venue in a central location, called a multidistrict litigation court, or Invokana MDL.
Invokana was only released in 2013, but has already grown to over 2.7 million prescriptions each year. The new drug is designed to treat type 2 diabetes by blocking the SGLT2 protein to prevent glucose absorption in the kidneys. It can also lower blood pressure and weight levels.
However, SGLT2 drugs have also been linked to a higher risk of ketoacidosis, or elevated acid levels in the blood. Symptoms of the condition include nausea, vomiting, abdominal pain, fatigue, and difficulty breathing, and it can range in severity from hospitalization to death.
The first of the Invokana lawsuits was filed in early December by a California woman who was prescribed the drug to control her type 2 diabetes blood sugar levels, but ended up hospitalized in 2013 for severe ketoacidosis. She is seeking more than $75,000 from Janssen and parent company Johnson & Johnson to help with medical bills.
In the second Invokana lawsuit, Texas plaintiff Arthur Portnoff claims he began taking the drug for diabetes in late 2014. By early 2015, he also developed a severe case of ketoacidosis requiring hospitalization.
Portnoff alleges that Janssen knew of the potential risks for patients to develop ketoacidosis, but didn’t properly notify doctors or consumers until forced to do so by the FDA.
A spokesperson for Janssen denied any undisclosed risks from the drug.
Warnings about the risks of Invokana ketoacidosis first surfaced for consumers in May of 2015, when the FDA issued an advisory alert that it had received an alarming number of adverse event reports since the drug’s approval.
The agency followed this up in December by requiring makers of the three major SGLT2 diabetes drugs: Invokana, Jardiance and Farxiga, to add warnings to their labels about both ketoacidosis and urinary tract infections.
Lawyers expect the number of ketoacidosis lawsuits will increase significantly once more patients learn that the drug could have caused their condition. DrugNews works with several large law firms currently investigating and filing these cases for patients, and can arrange for a lawyer to speak with you today at your request.
Contact us today for more information.
Sundar, S. Janssen Sued Over Diabetes Drug's Blood Disorder Risk. Law360. (December 14, 2015). Retrieved from www.law360.com
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