A growing number of patients are reporting a range of serious or permanent Invokamet side effects after using the diabetes drug, including diabetic amputation and major kidney problems.

The U.S. Food and Drug Administration (FDA) issued warnings—first in May 2015 and again in 2017—about the increased risk of certain serious side effects associated with a variety of type-2 diabetes medications, including Invokamet. Complications linked with the diabetes drug include diabetic amputation, ketoacidosis, and kidney failure.

Basics of Invokamet

Invokamet belongs to a class of drugs known as a sodium-glucose cotransporter-2 (SGLT2) inhibitors, which are used to treat type-2 diabetes. Invokamet is also known by its generic name, canagliflozin metformin. Other drugs in this class include Invokana and Invokamet XR.

In order to treat type-2 diabetes, Invokamet works to lower a patient’s blood sugar. Invokamet is intended to treat type 2 diabetes by lowering blood sugar through the combined use of canagliflozin and metformin. Canagliflozin helps your kidneys to get rid of glucose in the bloodstream, while the metformin component lowers the liver’s production of glucose.

SGLT2 inhibitors like Invokamet are a popular option for diabetes treatment. However, despite the widespread usage of these drugs, more and more patients are coming forward with reports of Invokamet side effects.

Invokamet Side Effects

Of course, any medication is expected to bring with it the risk of certain mild side effects. But many of the Invokamet complications being reported are far more serious in nature.

The FDA received reports of 20 cases of diabetic ketoacidosis, ketoacidosis, and ketosis found in patients treated with these SGLT2 inhibitors in around a one-year period from March 2013 to June 2014. The conditions were serious enough that the patients were either hospitalized or treated in the emergency room. Numbers have increased in the years since.

Mild Invokamet side effects include difficulty breathing, nausea, vomiting, abdominal pain, confusion, and fatigue. More serious side effects may include dangerous allergic reactions, kidney problems, kidney failure, and diabetic amputation.

Studies show that patients on Invokamet and similar medications are twice as likely to have to undergo lower limb diabetic amputation than patients taking a placebo. In some actual cases, patients had more than one lower limb amputation.

The FDA Warning

The FDA issued a safety announcement in May 2016, warning patients taking Invokamet and similar drugs of the serious risks associated with SGLT2 inhibitors.

It stated that “Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.”

Three years later, in May 2019, the FDA required the drug to carry stronger warnings – adding a “black box” warning to the label. Black box warnings call attention to life-threatening risks. The FDA decided the label was needed after seeing updated data from two clinical trials that looked at the type 2 diabetes medicine canagliflozin.

Diabetic Amputation

The news that Invokamet may increase a risk of amputation is particularly concerning because diabetic patients are already at an elevated risk for lower limb amputations. Patients rely on diabetes drugs like Invokamet to help decrease their risk of dangerous complications of diabetes, not increase the risk. 

It is not yet known why Invokamet may be linked to increased risk of amputations, says Endocrine Web. However, the reasons behind diabetes patients’ already elevated risk amputation may give insight into why Invokamet may exacerbate this risk. 

Neuropathy, or numbness, is one complication of diabetes. In the case of most people, if they get an injury on part of their body, they will feel the pain and be able to take steps to treat the problem. However, diabetes patients who are unable to feel their extremities may not be Abel to deal with an injury if one exists, which can make the problem worse. Additionally, diabetes decreases a patient’s ability to heal from wounds. So, if a wound occurs, it can quickly worsen, and possibly become infected. In severe cases, amputation may be required to deal with the infection.

This is a serious issue for diabetes patients. Reportedly, diabetic foot ulcers are the most common reason why diabetic patient will be hospitalized. Around 15 percent of people with diabetes will develop an ulcer at some point. Unfortunately once the ulcer has developed, the prognosis is not positive. Around 24 percent of people who get a foot ulcer will then need an amputation.

Endocrine Web goes on to explain that Invokamet works via the kidneys, so the drug may cause a person to become dehydrated. The constriction of blood vessels and reduced blood flow that comes with dehydration may increase a person’s risk of infection, and therefore, amputation.

Filing a Lawsuit Over Invokamet Side Effects

Lawsuits allege that the drug’s manufacturer either knew or should have known about the serious Invokamet risks like diabetic amputation, yet failed to adequately warn the public and the medical community.

If you or someone you love has suffered from Invokamet side effects, such as kidney damage or diabetic amputation after taking Invokamet or a similar SGLT2 inhibitor, you may have cause for filing a lawsuit. Though filing a lawsuit cannot take away the pain and suffering caused by Invokamet side effects, it may help alleviate the financial burden caused by bills and lost wages.