Federal Regulators Warn of Diabetic Ketoacidosis Side Effects of Invokana and SGLT2 Inhibitors

Federal regulators are warning consumers and the medical community that a potentially life-threatening condition called diabetic ketoacidosis may be linked to a popular class of diabetes drugs known as SGLT2 (sodium-glucose cotransporter-2) inhibitors.

​Federal regulators are warning consumers and the medical community that a potentially life-threatening condition called diabetic ketoacidosis may be linked to a popular class of diabetes drugs known as SGLT2 (sodium-glucose cotransporter-2) inhibitors. According to the FDA, “Diabetic ketoacidosis and ketoacidosis, serious conditions in which the body produces high levels of blood acids called ketones, have been reported in patients using the diabetes medicines known as [SGLT2] inhibitors,” which are widely used in the treatment of Type 2 diabetes in adults. If you or a loved one has suffered diabetic ketoacidosis, and you believe side effects of an SGLT2 inhibitor to be the cause, consult a knowledgeable product liability lawyer today to discuss your legal options.

What is Diabetic Ketoacidosis?

Diabetic ketoacidosis (DKA) is a serious complication of diabetes in which the body produces excess levels of blood acids called ketones. DKA typically occurs when the body is unable to produce enough insulin, a hormone made by the pancreas that plays a key role in helping the muscles and other tissues in the body use blood sugar (glucose) for energy. Without enough insulin, the body may begin to break down fats as an alternate source of fuel, which results in a buildup of toxic acids (ketones) in the bloodstream. Without treatment, excessive levels of ketones in the blood may lead to diabetic ketoacidosis.

In most cases, DKA occurs in patients with Type 1 diabetes who have high blood sugar levels. However, instances of diabetic ketoacidosis have been reported in patients with Type 2 diabetes who have near-normal glucose levels, a complication that is believed to be linked to the use of SGLT2 inhibitor drugs. Diabetes patients taking SGLT2 inhibitors are urged to be aware of the most common symptoms of diabetic ketoacidosis, which include difficulty breathing, nausea, vomiting, confusion and unusual fatigue, to avoid further complications, which may include diabetic coma and death.

DKA Warnings for Users of SGLT2 Inhibitors

Since the first SGLT2 inhibitor drug entered the market in the U.S., the medications have been marketed by their manufacturing companies as a safe and effective way to treat Type 2 diabetes in adults. Invokana was the very first SGLT2 inhibitor to be approved by the FDA, and the medication leads the category in terms of sales, bringing in a whopping $278 million during the first quarter of 2015 – a huge increase from the same period of 2014. In spite of the popularity of the Type 2 diabetes drugs however, serious concerns have been raised about the potential safety risks of the medications, and the FDA and other drug regulatory agencies have issued warnings to consumers and the medical community indicating that SGLT2 inhibitors may be tied to an increased risk of diabetic ketoacidosis and other potential side effects.

In May 2015, the FDA issued a drug safety communication warning that “the type 2 diabetes medicines canagliflozin [Invokana], dapagliflozin [Farxiga] and empagliflozin [Jardiance] may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.” In its safety announcement, the FDA highlighted “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.” The agency also noted that it would continue to investigate the potential connection between SGLT2 inhibitors and diabetic ketoacidosis, and determine whether the risk required updated warnings on SGLT2 inhibitor drug labels.

A Knowledgeable SGLT2 Inhibitor Attorney Can Help

Diabetic ketoacidosis is diagnosed in approximately 200,000 to three million people every year, and diabetes patients taking SGLT2 inhibitor drugs may have an increased risk of suffering from the potentially life-threatening condition, according to recent warnings issued by the FDA. If you took an SGLT2 inhibitor like Invokana or Invokamet, and you have since been diagnosed with diabetic ketoacidosis, contact a reputable drug injury attorney for legal help. You may have grounds to file a product liability lawsuit against the drug manufacturing company, in order to pursue financial compensation for your injuries, medical expenses, and other damages allegedly related to the condition. For more information on Invokana lawsuits, please visit us at http://drug-lawsuits.com/.

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