Considering the seriousness of this matter, Our Firm felt it was important to provide the public with a resource where they could access updated information regarding potential safety concerns related to drugs like Invokana.
New York, New York (PRWEB) June 11, 2015
Bernstein Liebhard LLP announces the launch of http://www.invokanalawsuitcenter.com, a new website intended to provide the public with updated information regarding a potential association between the use of sodium-glucose cotransporter-2 (SGLT2) inhibitors like Invokana and diabetic ketoacidosis, a dangerous condition that can lead to hospitalization, diabetic coma and even death. The Firm launched the new website in response to a Drug Safety Communication issued by the U.S. Food & Drug Administration’s (FDA) on May 15th, which revealed that the agency was investigating numerous reports of SGLT2 patients who had developed this condition. The FDA’s investigation will determine whether changes are needed in the prescribing information for this class of Type 2 diabetes medications.
“Considering the seriousness of this matter, Our Firm felt it was important to provide the public with a resource where they could access updated information regarding potential safety concerns related to drugs like Invokana. We are monitoring this situation closely, and look forward to additional guidance from the FDA once it completes its safety review,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is seeking to hear from Type 2 diabetes patients who were hospitalized following a diagnosis of diabetic ketoacidosis, acidosis, ketoacidosis, or ketosis, allegedly due to their use of SGLT2 inhibitors.
FDA Drug Safety Communication
Invokana was approved by the FDA in March 2013, and was the first SGLT2 Inhibitor cleared for sale in the U.S.* Other Type 2 diabetes drugs in this class include Invokamet (canagliflozin and metformin); Farxiga (dapagliflozin); Xigduo XR (dapagliflozin and metformin extended-release); Jardiance (empagliflozin); and Glyxambi (empagliflozin and linagliptin).**
According to the FDA, a search of the Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis (reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis) in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014. All patients required emergency room visits or hospitalization to treat the ketoacidosis. Since June 2014, the FDA has continued to receive additional reports for diabetic ketoacidosis and ketoacidosis in patients treated with SGLT2 inhibitors.**
Ketoacidosis is a dangerous condition that occurs when the body produces excessive levels of blood acids called ketones. Symptoms may include difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. According to the FDA, diabetic ketoacidosis is a condition that generally affects Type 1 diabetes and is accompanied by high blood sugar levels. The cases reported to the FAERS database were unusual, in that most of the patients had Type 2 diabetes, and reported blood sugar levels were only slightly elevated.**
Individuals who were allegedly hospitalized with diabetic ketoacidosis due to their use of Invokana or another SGLT2 inhibitor may be entitled to compensation for medical bills, lost wages, pain and suffering, and other damages. To find out more about available legal options, please visit Bernstein Liebhard LLP’s website, or call the Firm directly at 800-511-5092.
*fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345848.htm, FDA, March 29, 2013
**fda.gov/Drugs/DrugSafety/ucm446845.htm, FDA, May 15, 2013
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3 billion on behalf of our clients. The National Law Journal has recognized Bernstein Liebhard for twelve consecutive years as one of the top plaintiffs' firms in the country. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since it was first published in 2003.
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ATTORNEY ADVERTISING. © 2015 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Sandy A. Liebhard, Esq.
Bernstein Liebhard LLP