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Invokana belongs to a newer class of Type 2 diabetes treatments called sodium-glucose co-transporter 2 (SGLT2) inhibitors, a class of medication that works by stopping glucose from being reabsorbed into the blood. The FDA warned Invokana can also cause ketoacidosis, a condition that requires hospitalization and can cause fatal swelling of the brain, severe dehydration and coma.
While many drugs work to increase insulin, Invokana works by stopping glucose from being reabsorbed into the blood in the kidneys. It acts by inhibiting a special protein in the kidney called SGLT2 that is responsible for reabsorbing 90 percent of the glucose in the kidneys. Instead of reabsorbing the sugar, the kidneys secrete it, and it leaves the body during urination. This results in lowered levels of glucose in the blood.
The most common Invokana side effects include:
Recent studies and FDA warnings link Invokana to a number of serious side effects that may be fatal. Many of these side effects also require hospitalization and intensive care or emergency treatment.
In May 2015, the FDA warned that Invokana may lead to a serious condition called diabetic ketoacidosis (DKA). DKA occurs when the body cannot use sugar (glucose) as a fuel source because there is either too little or no insulin. Instead, the body breaks down fat for energy. The breakdown of fat produces ketones which can build up in the body. When these waste products build up in the blood, they become toxic.
According to the FDA warning, the agency received about 20 reports of ketoacidosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014. All of these patients needed to go to the hospital for treatment. Since then, the FDA said they are still receiving reports of ketoacidosis in relation to these drugs. The agency ordered manufacturers to add warnings to the drugs' labels in December 2015.
DKA is a serious condition and patients who notice any of these symptoms should contact a doctor or emergency room immediately.
Symptoms of DKA include:
In June 2016, the FDA strengthened the acute kidney injury (AKI) warning for Invokana. Kidney injury is a serious condition where the kidneys suddenly stop working and allow waste to build up in the body. According to the FDA, more than 100 people reported suffering kidney injury after taking Invokana or another SGLT2 drug, Farxiga, between March 2013 and October 2015. The agency says there may be more unreported cases. About half of reported cases occurred within one month of starting the drug.
In some cases, AKI may not have symptoms, and healthcare providers may have to run some tests to diagnose it. The FDA recommends patient who have signs of kidney injury stop taking Invokana immediately.
Symptoms of AKI include:
In December 2015, the FDA warned that Invokana can increase the risk of serious or life-threatening blood infections (urosepsis) that started as UTIs. The agency identified 19 cases of blood infections and kidney infections (pyelonephritis) from March 2013 to October 2014.
The FDA recommends that patients contact a healthcare provider immediately if they suffer these symptoms.
Symptoms of UTIs include:
Symptoms of blood infection include:
The FDA also required Johnson & Johnson to conduct post marketing studies and a clinical trial after initial study data showed a troubling increase in the risk of cardiovascular problems such as stroke, blood clots (thromboembolic events) and heart attacks. The CANVAS trial showed a 46 percent elevated risk for stroke in the first 30 days of treatment.
In 2016, the FDA said it received reports of acute pancreatitis in patients taking Invokana and other SGLT2 inhibitors. Acute pancreatitis occurs when the pancreas, the organ responsible for making insulin, becomes inflamed and swollen. It can lead to serious health problems and death if untreated. Treatment for mild cases typically involves antibiotics. For more serious cases, doctors may hospitalize patients for emergency treatment.
In its Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) list from April to June 2016, the agency said it was "evaluating the need for regulatory action" for acute pancreatitis for all drugs in the class.
A handful of the studies on acute pancreatitis and SGLT2s primarily focus on case reports related to Invokana.
One case study from 2015 published in Therapeutics and Case Management by Dr. Mudit Chowdhary and colleagues treated a patient who reported to the ER after experiencing vomiting, pain and nausea for two days. They concluded it was acute pancreatitis caused by Invokana.
In a second 2015 case study written by Dr. Narat Srivali and colleagues in the Journal of Basic Clinical Pharmacy, a patient developed diabetic ketoacidosis caused by acute pancreatitis after taking Invokana for four days. Doctors determined Invokana caused the problems.
Both patients recovered after they stopped taking Invokana.
|The most common side effects were:|
|Dehydration and thirst||Discomfort during urination|
|Increased urination||Increased Cholesterol|
|Kidney problems||Low blood sugar|
|Urinary tract infections||Yeast infections in men and women|
This drug has a pregnancy risk category of C. This means there are no tests or data from pregnant women and risk cannot be ruled out. But in rats, Invokana affected kidney development. These medications should only be used if the risk outweighs the benefit.
There are no tests to determine if these drugs are excreted in human breast milk, but levels of the drug were found in the milk of rats. There may be risk to the developing human kidney if babies ingest milk with traces of these drugs. Before breastfeeding, mothers should talk to their doctors.
The safety or effectiveness of these drugs has not been tested in children under 18.
Clinical studies show that patients 65 and older typically suffer more side effects from these medications. With Invokana, patients suffered from low blood pressure, dizziness and dehydration. The drugs were less effective in older people with poor kidney function. These drugs also caused more kidney failure in older patients. These side effects worsened for patients 75 or older.
Placebo-controlled clinical trials for Invokana involved 584 participants who had Type 2 diabetes that was not controlled with diet and exercise. The trial lasted 26 weeks. The average age was 55 years old. At the end of the trial people who took Invokana achieved an HbA1C less than 7 percent.
In four studies for the safety of the drug, 1,667 patients took Invokana for about 24 weeks. Most people in the study had Type 2 diabetes for about 7 years. In the study, the most common side effects participants suffered were yeast infections and urinary tract infections. About 10 percent of women and 4 percent of men suffered from yeast infections because of the large amount of sugar in urine.
Invokamet (canagliflozin and metformin) takes the active ingredient in Invokana and adds metformin. Because of this, the drug has a black box warning for lactic acidosis. If patient suspects this condition, they should go to the hospital immediately.
People with Type 2 diabetes have numerous treatment options to discuss with their health care providers.
The most basic recommendation is eating a healthy diet that will help patients maintain healthy weight, blood pressure, cholesterol levels and blood glucose levels. Leading a lifestyle that includes exercise or regular physical activity is also highly recommended.
Some doctors may prescribe insulin shots, pumps or injectors. It’s important to take them as prescribed.
All diabetes medications carry a risk of side effects, and the benefits of each medication should be greater than its risks. In addition to SGLT2 inhibitors, types of diabetes medications include:
Other organizations like the American Diabetes Association, the U.S. National Library of Medicine and the National Institute of Diabetes and Digestive and Kidney Disease have a wealth of information available online.
Patients looking for help planning healthy meals may want to consult a nutritionist or dietician. Organizations like Weight Watchers also offer weight loss and weight maintenance plans specifically designed for diabetics.