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We are currently investigating potential lawsuits for those harmed by the type 2 diabetes mediation Invokana.
Scientific studies and a recent FDA warning have raised concerns about the type 2 diabetes drugs, Invokana (canagliflozin) and Invokamet (canagliflozin/metformin). Patient and doctor reports have linked its use to dangerous side effects, including diabetic ketoacidosis, kidney failure and damage, myocardial infarction (heart attacks), and other cardiovascular injuries.
With the new information coming forth about the potential dangers associated with this product, it is important to be aware of your rights. If you suffer serious injuries while using Invokana, contact the plaintiffs-only attorneys at Chaffin Luhana for help. They are experienced with these types of cases and can help guide you concerning your right to compensation.
Invokana is a type of drug called a “sodium-glucose co-transporter 2 (SGLT-2) inhibitor.” It is used in combination with diet and exercise for the treatment of type 2 diabetes.
As designed, the drug prevents the kidneys from reabsorbing glucose, causing more of it to be flushed out of the body via the urine. The goal is to reduce the overall amount of glucose in the blood.
The drug is manufactured by Janssen Pharmaceuticals, Inc. (and parent company Johnson & Johnson). They advertised Invokana as an improved alternative to other type 2 diabetes medications, belonging to the “newest class of medicines” that work with the kidneys to reduce blood sugar levels.
There were some early concerns, however, which prompted the FDA to require additional studies of the drug—but in the meantime, they allowed it to be sold on the market. Janssen Pharmaceuticals, Inc. agreed to conduct additional post-market studies of its drug for the following:
Within a year of its FDA approval, Invokana had appeared several times in patient and doctor reports of health problems. These reports were sent to both Janssen Pharmaceuticals, Inc. and the FDA. By the second quarter of 2014, the drug was linked with 457 of these reports—a number higher than 92 percent of the drugs regularly monitored by the Institute for Safe Medication Practices (ISMP).
In the ISMP QuarterWatch report for 2014 (second quarter), the authors questioned the safety of the drug, reporting: “[a]lso, early signals for a new kind of diabetes drug, canagliflozin (INVOKANA) raise questions about whether enough is known about this agent to be assured that its benefits outweigh its risks.” They added that there were questions even at the time of FDA approval, when the administration expressed the concern that the long-term consequences of taking the drug were unknown, and that it was “prudent to assume” that the slight reduced kidney function seen in the studies “places patients at increased risk for clinically significant episodes of acute kidney injury.” If you or a loved one has suffered an injury from this drug and want to file a invokana lawsuit, contact an experienced national invokana lawyer for a free legal consultation.
Data linking Invokana to an increased risk of certain serious side effects came to light in the early clinical trials used to gain FDA approval. In those studies, for example, 14 percent of women and nearly 4 percent of men developed fungal infections at rates 4-6 times those in patients taking other drugs.
Animal studies in which researchers exposed subjects to higher-than-normal doses of the drug also resulted in an increased risk of kidney damage, bone abnormalities, and kidney and testicular cancers. This is why the FDA required additional studies on the drug to further examine these risks. Before the administration actually approved the drug, watchdog group Public Citizen urged them to be cautious.
Dr. Sidney Wolfe, director of the group’s health research, noted that because Invokana worked to lower blood glucose in a whole new way, it was likely to come with previously unknown risks.
He further explained that “The fact that the drug works by a uniquely new mechanism to lower blood sugar has not spared of a whole set of unique new risks”. After the drug went to market, other studies came to light that raised concerns about the safety of SGLT2 inhibitors, including Invokana. In 2014,researchers found that in addition to lowering glucose levels, an SGLT2 inhibitor similar to Invokana also increased the body’s production of glucose and glucagon (a hormone that raises blood sugar levels), as if compensating for the drug’s effects. In another study that same year, researchers again found that even though the SGLT2 inhibitor used in the study decreased blood sugar levels, it also boosted glucose production and glucagon response.
In May 2015, the FDA warned about yet another potential Invokana side effect: diabetic ketoacidosis (DKA). This is a serious condition in which the blood becomes too acidic, and can lead to complications like dehydration, coma, and even death in severe cases.
How could Invokana lead to this condition? It was puzzling, as typically patients with type 1 diabetes are at a greater risk for developing this condition than those with type 2 diabetes. Yet, the FDA received 20 reports of people with type 2 diabetes developing the condition between 2013 and 2014, and more reports have continued to come in since then.
The condition can develop in patients with type 1 diabetes because the body lacks enough insulin to properly break down glucose. In response, the body breaks down fat, instead, for fuel. This process releases byproducts called “ketones” into the blood. These are acidic, but usually the kidneys maintain blood pH balance by flushing the excess ketones out through the urine. In patients with type 1 diabetes, however, this balance can be thrown off, resulting in DKA.
The condition is much more rare in patients with type 2 diabetes, which is why these reports concerned the FDA. Though we don’t know the precise mechanism by which those patients taking Invokana developed DKS, researchers believe it has something to do with how Invokana interrupts kidney function. It may be that the drug inhibits the flushing of excess ketones, resulting in an unhealthy pH balance in the blood.
Symptoms of ketoacidosis may include:
If you or a loved one experiences symptoms like these, see your doctor right away. The FDA continues to investigate the issue.
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Drug companies like Janssen Pharmaceuticals, Inc. are responsible for making sure their products are effective and safe for use. Early evidence suggests that the drug manufacturer did not do enough to protect the public from potential harm. If you or a loved one took Invokana or Invokamet and then suffered from DKA, kidney failure, cardiovascular injury, or other serious side effects, you could be eligible to file a personal injury lawsuit. Contact Chaffin Luhana today for a free initial consultation. We will investigate the facts of your case and help guide you toward the best option in your attempt to recover damages. Call 1-888-316-2311.
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