Drug injury lawyers across the United States are investigating adverse event reports involving patients who have experienced potentially life-threatening side effects like diabetic ketoacidosis, heart attack and kidney failure while taking the new-generation Type 2 diabetes drug Invokana. Since Invokana first became available for consumer use in the United States, just a few years ago, the diabetes medication has been tied to an increased risk of potentially life-threatening complications in patients. If you or a loved one took Invokana in the past, and you have since suffered diabetic ketoacidosis (DKA) or another severe side effect, contact a reputable Invokana lawyer today for legal help. You may be entitled to financial compensation for your injuries, medical expenses, and pain and suffering, which you can pursue by filing a product liability claim against Invokana maker Janssen Pharmaceuticals and its parent company, Johnson & Johnson.
The first in a new generation of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, Invokana (canagliflozin) was designed to be used with diet and exercise to improve glycemic control in adults diagnosed with Type 2 diabetes. Normally, when a person consumes food, the body produces insulin to process the sugar, but in people with Type 2 diabetes, this process doesn’t occur the way it’s supposed to, and that person develops an insulin resistance. What eventually happens, is the pancreas is unable to keep up with the demand for insulin, and the level of sugar in the bloodstream increases to dangerous levels. That’s where Invokana and other SGLT2 inhibitors come in.
Invokana is administered orally and functions by preventing sugar from being reabsorbed into the blood by the kidneys, while also increasing glucose excretion through the urine, thereby lowering blood glucose levels in patients with Type 2 diabetes. Invokana was first approved by the U.S. Food and Drug Administration (FDA) in March 2013, and is currently manufactured by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary. In May 2015, just two years after Invokana became available for consumer use, the FDA issued a warning indicating that patients taking the SGLT2 inhibitor may have an increased risk of developing a potentially fatal condition called diabetic ketoacidosis, and other serious side effects.
Statistics from the FDA show that approximately 1.1 million patients received Invokana prescriptions, and approximately 41,000 patients received Invokamet prescriptions, from U.S. pharmacies during the 12-month period between July 2014 and June 2015. However, despite clinical trials demonstrating the safety and effectiveness of Invokana treatment for Type 2 diabetes, serious concerns have been raised recently about the potential for the diabetes drug to cause severe and possibly even life-threatening side effects in patients. Among the adverse health consequences allegedly linked to Invokana use are:
Diabetic ketoacidosis occurs when the body is unable to use sugar as a source of fuel, because there is either too little or no insulin available in the body. Instead, the body begins to break down fat for energy, and this process produces ketones, which can build up in the blood and become toxic. According to the FDA, diabetic ketoacidosis typically occurs in patients with Type 1 diabetes, and is usually accompanied by high blood sugar levels. However, adverse event reports submitted to the FDA in recent years have involved DKA side effects in Type 2 diabetes patients with only slightly elevated blood sugar levels.
According to recent research, diabetic ketoacidosis can lead to serious complications like diabetic coma or death, and the condition is considered a medical emergency. The symptoms most commonly associated with diabetic ketoacidosis include:
For patients with Type 2 diabetes taking Invokana or another SGLT2 inhibitor, it is recommended that they look out for any symptoms of diabetic ketoacidosis, and seek medical attention immediately if one or more of these symptoms arise.
During the drug trials conducted before Invokana was approved by the FDA, patients using the diabetes medication were found to have a higher risk of developing fungal infections, and animal studies found that long-term use of Invokana was tied to kidney damage, abnormalities in the bones, and testicular and kidney cancers. When the FDA approved Invokana for consumer use in 2013, the agency required five post-marketing studies for Invokana safety and effectiveness, including “a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamics study and a safety and efficacy study.”
After Invokana became available for consumer use in the United States, Janssen began marketing the medication as a safe and effective treatment for Type 2 diabetes in adults, and also claimed that Invokana can help with weight loss, which is always a popular selling point for diabetes drugs. However, a clinical study of patients at high risk for cardiovascular disease showed that, within the first 30 days, 13 study participants taking Invokana suffered a major cardiovascular event, compared to just one study participant taking a placebo. The clinical trial also found a slight increase in unhealthy LDL cholesterol associated with Invokana treatment. More recently, an editorial published in the medical journal Diabetes Care in October 2015, indicated that Invokana was associated with a higher rate of diabetic ketoacidosis side effects than other SGLT2 inhibitor medications during clinical trials.
Across the United States, patients with Type 2 diabetes continue to take Invokana and other SGLT2 inhibitors, under the impression that the new-generation medications will reduce their risk of diabetes complications without putting them at risk for serious complications. However, research has shown that Invokana treatment may be linked to an increased risk of diabetic ketoacidosis and other major side effects, a link that many consumers are not aware of, because Johnson & Johnson and its Janssen Pharmaceuticals subsidiary have allegedly failed to provide the public with adequate warnings about the potential health risks of Invokana. By hiring a reputable Invokana attorney, you can educate yourself about your legal rights when it comes to suffering side effects from pharmaceutical drugs, and find out what you may be entitled to as far as financial compensation goes. Only product liability lawyers familiar with Invokana litigation can adequately represent the interests of yourself and your family. Contact an experienced Invokana lawyer today to discuss your legal options.
Just about two years after Invokana entered the market for sale in the United States, the FDA finally issued a drug safety communication warning consumers and the medical community about the potential link between SGLT2 inhibitors like Invokana and diabetic ketoacidosis side effects. According to the FDA warning, at least 20 cases of acidosis identified as diabetic ketoacidosis, ketoacidosis or ketosis were reported among patients treated with SGLT2 inhibitors between March 2013 and June 6, 2014, and all affected patients required emergency room visits or hospitalization to treat the ketoacidosis. The FDA also reported at that time, that the agency continues to receive reports of DKA and ketoacidosis in patients treated with SGLT2 inhibitors like Invokana.
Shortly after the FDA issued its Invokana warning, the Institute for Safe Medication Practices (ISMP) issued its own report regarding the risk of adverse events allegedly associated with Invokana, and warned that the rate of side effects from Invokana was higher than 92% of all the medications the agency monitors. According to the ISMP, during the first year Invokana was on the market in the United States, there were more than 450 adverse event reports submitted by users of the SGLT2 inhibitor, including 54 cases of fluid imbalance or severe dehydration, 54 cases of kidney failure, 52 cases of abnormal weight loss, 50 cases of urinary tract infections, 50 cases of allergic reactions to the drug, and 11 cases of kidney stones.
In another drug safety communication released by the FDA in September 2015, the agency warned that patients taking Invokana may face an increased risk of bone fractures and bone mineral density loss as soon as 12 weeks after beginning treatment with the diabetes drug. Even more alarming, the agency warned that, according to Invokana clinical trials, when trauma occurred prior to a fracture, it was typically minor, such as a fall from no more than standing height. According to the FDA, the agency will continue to evaluate the risk of bone fractures and loss of bone mineral density related to Invokana and other SGLT2 inhibitors, to determine if additional label changes or studies are necessary.
In the wake of the FDA warning regarding the potential link between Invokana treatment and diabetic ketoacidosis side effects, attorneys are considering claims brought on behalf of patients across the country who have suffered DKA and other severe complications allegedly caused by the use of the SGLT2 inhibitor drug. All of the Invokana lawsuits brought against Janssen Pharmaceuticals in the coming months and years will likely involve similar allegations that the drug maker: manufactured a defective drug; misrepresented the benefits and risks of Invokana treatment; failed to warn consumers and the medical community about the potential side effects of Invokana; and continued to market Invokana as a safe and effective medication, despite these risks.
Type 2 diabetes is a serious medical condition that affects approximately 24 million people, and accounts for more than 90% of diabetes cases diagnosed in the United States. Unfortunately, a growing body of evidence suggests that new-generation Type 2 diabetes drugs like Invokana and other SGLT2 inhibitors may expose users to potentially life-threatening side effects, including diabetic ketoacidosis. In fact, based on reports highlighted by the FDA and other drug safety regulators, the risk of diabetic ketoacidosis and other side effects from SGLT2 inhibitors like Invokana is significantly higher than expected. If you believe you have been adversely affected by serious complications from Invokana, consult a knowledgeable Invokana attorney today to discuss your legal options. With a skilled drug injury lawyer on your side, you can protect your legal rights and pursue the financial compensation you deserve for your injuries.