What is Invokana?
Invokana is in a new class of medication called SGLT2 inhibitors used to treat Type II diabetes. Phase III clinical trials of the drug showed patients taking Invokana reduced their overall body weight and systolic blood pressure and improved their blood glucose control. Invokana reduces blood glucose via the kidneys, increasing glucose loss in the urine. Normally when glucose is filtered out through the kidneys, it is reabsorbed back into the bloodstream; however, Invokana blocks this response and can trigger dangerous levels of blood acids which can lead to coma and even death. After reviewing adverse events reports, the FDA issued a warning regarding all of the drugs in this class.
Heart Attack and Stroke Related to Invokana
In one Invokana trial conducted by Janssen Pharmaceutical Company (a subsidiary of Johnson & Johnson) there was an increase in heart attack and stroke among those taking the drug. The risk occurred within the first thirty days the patient took Invokana. Thirteen patients who took Invokana in the trial suffered a major cardiovascular event within the first thirty days, compared with one patient taking a placebo. While the risk of a major cardiovascular event reversed after the first thirty days, a significant increase in LDL cholesterol was seen among those taking Invokana. Despite the results of this trial, the FDA did not require warnings on the labeling of Invokana warning about potential heart attack and stroke risks.
Potential Risks of Kidney Failure and Bladder Cancer among Those Taking Invokana
Another health concern regarding Invokana is the risk of kidney failure and bladder cancer. Many of those who suffer from Type II diabetes already have some level of kidney disease. Some research pointed to a worsening of kidney disorders among those taking Invokana. The labeling on Invokana does state that Invokana can increase serum creatinine and decrease eGFR in the body. Studies show that those over the age of 75 are the most likely to suffer a severe kidney disorder while taking Invokana. While no clinical trials done by Janssen pointed to an increased risk of bladder cancer, some other studies noticed a tendency of the drug to lead to infections which could then be “causal of new cancers.”
FDA Drug Safety Announcement Regarding Serious Health Risks of Ketoacidosis
As recent as May 2015, the FDA warned that medications such as Invokana could put patients at risk for a serious health condition known as ketoacidosis. Ketoacidosis develops when the patient is unable to produce sufficient insulin. Insulin allows sugar (glucose) to ender the body’s cells, providing needed energy to tissues and muscles. When the body lacks insulin, it breaks down fat to provide energy, producing a buildup of toxic acids in the bloodstream.
Ketoacidosis can lead to coma and even death. The American Diabetes Association describes ketoacidosis as a condition which causes the body to produce excessive levels of blood acids or ketones. The FDA warning came after the agency reviewed twenty adverse event reports from patients who ended up seriously injured or hospitalized after taking Invokana and suffering ketoacidosis. Symptoms of ketoacidosis include trouble breathing, abdominal pain, nausea and vomiting, unusual sleepiness, unusual fatigue and mental confusion.
The following factors can increase your likelihood of having medical problems while taking Invokana: high cholesterol, a low-salt diet, heart disease, liver disease, kidney disease, high blood pressure, low blood pressure, electrolyte imbalance or the use of insulin or oral diabetic medications. If you have suffered, serious, adverse symptoms related to Invokana, it could be beneficial to speak to a personal injury attorney who is familiar with Invokana and the current lawsuits against the manufacturer. You could be entitled to recover compensation for medical expenses, pain and suffering and loss of income.
Contact Our National Dangerous Drug Lawyers
At Golomb Legal, P.C., our dangerous drug lawyers have considerable experience and success representing patients and families that have been injured by a negligent drug manufacturer. If you or someone you love has suffered injury after taking the dangerous drug Invokana, we can help.
To learn more about your rights and legal options, call the Philadelphia defective drug lawyers at Golomb Legaltoday at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.