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In response to recent concerns expressed by federal drug regulators about the potential link between Invokana and ketoacidosis, following a number of reports involving users hospitalized following use of the new-generation diabetes drug, a leading medical group will convene a group of experts to review the potential risk during a fall conference.
The American Association of Clinical Endocrinologists (AACE) has scheduled a conference for experts from the U.S. and around the world to review the risk of diabetic ketoacidosis that may be associated with side effects of Invokana and other similar diabetes drugs that are part of a class of medications known as sodium-glucose-cotransporter-2 (SGLT2) inhibitors.
The conference will be held on October 24-25 at the Grand Hyatt DFW in Dallas, coming after the FDA announced that it is reviewing whether regulatory actions are necessary as a result of ketoacidosis problems with Invokana and other SGLT2 inhibitor diabetes drugs.
Invokana (canagliflozin) was approved by the FDA in March 2013, as the first in a new class of diabetes medications that work in a unique way by impacting the normal function of the kidney, causing an increased amount of sugar to be excreted in the urine. Over the past two years, other new drugs have been approved in this same class, including Farxiga, Invokamet, Glyxambi, Jardiance, and Xigduo XR. However, Invokana was the first to market and is the most widely used of the new-generation of drugs.
Concerns about the potential Invokana side effects emerged in May, when the FDA issued a drug safety communication that indicated during the first 15 months Invokana was on the market, more than 20 adverse event reports were received involving individuals using an SGLT2 inhibitor who required emergency room treatment or hospitalization due to diabetic ketoacidosis, ketosis, acidosis or other related conditions.
Ketoacidosis occurs when high levels of blood acids, known as ketones, build up in the blood. This can result in symptoms like difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, often requiring urgent medical treatment and potentially resulting in severe health consequences.
Although diabetic ketoacidosis is commonly associated with type 1 diabetes, it is not normally seen among patients diagnosed with type 2 diabetes, which is the type of diabetes Invokana and the other drugs are approved to treat. Type 2 diabetes is an acquired and curable condition, while type 1 diabetes is usually something someone is born with and persists for life.
AACE represents more than 6,000 experts who regularly treat diabetic patients, and the group indicates that it hopes the conference will answer questions about the drugs that have recently been raised by its members in recent months. The group will examine the FDA data and other recent studies and give recommendations to both the medical community and patients.
“AACE’s responsibility to its members and their diabetes patients is to conduct a complete, objective and balanced evaluation of the data and investigate any knowledge gaps before issuing our recommendations,” AACE President Dr. George Grunberger said in the press release. “There are still unanswered questions to answer before we draw any definitive conclusions on the subject, and that is what this conference is designed to do.”
Invokana Health Concerns
Since Invokana hit the market, several potential safety concerns have emerged, raising questions among some doctors and experts about whether the risks associated with SGLT2 inhibitors may outweigh the minimal benefits provided by the type 2 diabetes treatments.
In addition to potential ketoacidosis side effects, questions have been raised about a potential link between Invokana and kidney failure, given the mechanism of action that impacts normal kidney function.
The Institute of Safe Medication Practices (ISMP) released a report in May that evaluated adverse event reports submitted to the FDA over the first year Invokana was on the market, identifying several safety signals involving kidney toxicity. The group raised questions about whether the potential Invokana risks may actually outweigh the benefits.
Looking at reports to the FDA’s adverse event reporting system, the ISMP found that Invokana received more serious adverse event reports than 92% of the other drugs regularly monitored by the group. Many of the reported Invokana problems involved kidney failure, kidney impairment or problems with kidney stones, urinary tract infections, dehydration, hypersensitivity and abnormal weight loss.
Given the emerging safety concerns and rush to market this new class of diabetes drug, some product liability lawyers are now reviewing whether individuals who suffered an injury may be entitled to financial compensation through an Invokana lawsuit or Farxiga lawsuit as a result of the drug makers’ failure to adequately research the potential risks and warn about the side effects.