FDA Invokana Warning for Diabetic Ketoacidosis
In 2015, just two years after the drug was first approved in the United States, the first FDA Invokana warning was issued, cautioning physicians and patients of the health risks such as ketoacidosis that had become associated with the drug. Prior to the FDA Invokana warning, the general public was unaware that kidney failure, ketoacidosis, heart attack, stroke and other dangers were posed by the drug. This page provides information about the contents of the FDA Invokana warning, as well as information from physicians regarding the safety of the drug.
The FDA safety announcement addresses the risk of ketoacidosis, or too much acid in the blood, posed by various Type II diabetes medications including canagliflozin (Invokana), dapagliflozin, and empagliflozin. Taking these drugs can reportedly result in fatal blood ketone levels. According to the FDA Invokana Ketoacidosis warning, the FDA is currently investigating whether these drugs’ labels should be altered to provide a warning about ketoacidosis.
FDA Warns of Diabetic Ketoacidosis from Invokana
Ketoacidosis is a life-threatening condition that requires emergency room care or hospitalization, according to the FDA Invokana warning. The warning was released on the basis of adverse event reports that were made to the FDA Adverse Event Reporting System (FAERS); federal regulators are continuing to monitor adverse event reports for Invokana blood acid problems.
Ketoacidosis is a life threatening condition, according to the FDA Invokana warning.
Diabetic ketoacidosis is a condition that develops in Type I diabetics when insulin levels become too low or when the patient is fasting. Invokana is only used in patients who suffer from Type II diabetes, so these reports are unexpected and researchers believe the connection is clear. Ordinarily, when a patient is diagnosed with diabetic ketoacidosis, they also have very high blood sugar; in patients taking the drug, their blood sugar levels were not particularly high. The FDA Invokana warning addresses several other lesser known drugs as well, including Invokamet, Farxiga, Xigduo XR, Jardiance, and Glyxambi.
Patients were not warned of the risks of ketoacidosis when they were prescribed with Invokana.
The Ketoacidosis Invokana warning describes symptoms of this condition as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue. Patients and physicians are encouraged to provide adverse event reports regarding cases of diabetic ketoacidosis in patients taking this or another sodium-glucose cotransporter 2 (SGLT2) inhibiting drug.
FDA Invokana Risk Assessment for Ketoacidosis, Kidney Failure and Other Health Problems
Since federal regulators first approved Invokana in the United States in 2013, the drug has been under investigation. In fact, one key stipulation of the drug’s approval was that the marketer, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) conduct five post market studies to track certain health risks of the drug. These studies track the following outcomes and risks:
- cardiovascular outcomes
- enhanced pharmacovigilance program
- bone safety study
- two pediatric studies
Initial data presented to the FDA showed Invokana is effective at lowering blood glucose levels. However, as it was the first in its class to be approved by the FDA (after other similar drugs had already been denied), the drug was evidently considered risky. The FDA has wasted no time in reviewing postmarket adverse event reports and issuing the first FDA Invokana warning. It is notable that the warning addresses ketoacidosis, a blood ketone imbalance that is potentially fatal, which was not among the initial concerns cited by the FDA when the drug was approved.
The FDA advisory panel was initially most concerned with Invokana cardiovascular risks. These risks include myocardial infarction (heart attack), stroke, unstable angina, and cardiovascular death.
FDA Invokana Ketoacidosis Reporting
Federal regulators request that individuals who have suffered serious health problems file an FDA Invokana report. FAERS, the Federal Adverse Event Reporting System is an online tool that serves as a database of drug side effects and health problems. Reports made regarding Invokana will help guide federal regulators to making future FDA Invokana warnings, should they be necessary.
Invokana Injury Lawyers Help Individuals and Families
Our attorneys handling Invokana lawsuits on behalf of persons and the families of persons who suffered from Invokana side effects such as blood acid problems, kidney failure, heart attack, stroke, wrongful death and other injuries are drug safety litigation experts. They will work tirelessly on your behalf to assure you get the compensation you deserve. If you or a loved one suffered from a serious health condition while taking Invokana, an experienced attorney can help by answering your questions and giving you a sense of your legal options.
Invokana Ketoacidosis and Kidney Lawsuits
Persons and the family members of persons who suffered from serious Invokana health problems such as heart attack, stroke, high blood acid levels, or kidney impairment may have grounds for an Invokana lawsuit. We provide legal representation for Invokana injury lawsuits on contingency basis, meaning that we charge no fee unless we win compensation on your behalf.