Invokana Lawsuit News: Bernstein Liebhard LLP Comments on Latest Invokana Safety Alert

September 11, 2015 - The U.S. Food & Drug Administration (FDA) has issued an alert regarding a potential association between Invokana and Invokamet (http://www.invokanalawsuitcenter.com/) and an increased risk of bone fractures and reduced bone density. According to a Drug Safety Communication issued by the agency on September 10th, it has added a new Warning and Precaution and revised the Adverse Reactions section of the drugs' labels to better reflect these safety concerns. The FDA action was prompted by new information from several clinical trials confirming that fractures were more likely among Invokana and Invokamet patients compared to those taking a placebo. The trials indicated that such fractures can occur as early as 12 weeks after treatment has begun, and may be associated with minor trauma, such as a fall from standing height.

The FDA is advising doctors to consider factors that contribute to fracture risk before starting patients on Invokana or Invokamet, and to counsel patients about these factors once treatment is initiated. The FDA is continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including Farxiga, Xigduo XR, Jardiance, Glyxambi, and Synjardy, to determine if additional label changes or studies are needed.

"This announcement comes just months after the agency revealed that it was reviewing a possible link between the use of Invokana and other SGLT2 inhibitors and the onset of diabetic ketoacidosis, a dangerous condition that can cause diabetic coma and death. Patients taking this class of medications should be aware that they may be associated with very serious side effects," 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 investigating potential Invokana lawsuits on behalf of Type 2 diabetes patients who were diagnosed with ketoacidosis, allegedly due to their use of this or another SGLT2 inhibitor.

FDA Diabetic Ketoacidosis Review
Invokana and other SGLT2 inhibitors control Type 2 diabetes by inhibiting the absorption of glucose by the kidneys, facilitating its elimination from the body via urine. Approved in March 2013, Invokana was the first of the class to come to market. Invokamet is a combination drug consisting of the active ingredient in Invokana and metformin.

The FDA announced in May that it was reviewing SGLT2 inhibitors after its adverse events database had logged 20 reports of acidosis (reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis) in patients treated with the drugs from March 2013 to June 6, 2014. Additional cases have since been reported to the database, according to the agency. The FDA's review will determine whether changes are needed in the prescribing information for SGLT2 inhibitors.

Diabetic ketoacidosis occurs when the body produces excessive levels of blood acids called ketones. The condition is generally seen in conjunction with Type 1 diabetes, but many of the incidents involving SGLT2 inhibitors occurred in Type 2 diabetics. The cases were also unusual in that blood sugar levels, when reported, were only slightly elevated. According to the FDA, all of the affected patients required emergency treatment, and some were hospitalized.

Bernstein Liebhard LLP is currently evaluating potential Invokana lawsuits on behalf of Type 2 diabetics who were hospitalized with ketoacidosis while using this drug or any other SGLT2 inhibitor. To learn more, please visit Bernstein Liebhard LLP's website, or call the Firm directly at 800-511-5092.

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 $3.5 billion on behalf of our clients. The Firm was named by The National Law Journal to the Plaintiffs' Hot List, recognizing the top plaintiffs firms in the country, for 12 consecutive years. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list for a dozen consecutive years.

Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
800-511-5092

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.

Contact Information:
Sandy A. Liebhard, Esq.
Bernstein Liebhard LLP
info (at)consumerinjurylawyers(dot)com
http://www.invokanalawsuitcenter.com/
https://plus.google.com/115936073311125306742?rel=author