Sage Datko  |  August 17, 2020

Category: Diabetes

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Invokamet may increase the risk of amputation.

The diabetes drug Invokamet is popular among people with type-2 diabetes, but the drug may be unsafe for certain people based on the increased risk of lower limb amputation in already at-risk diabetics.

What is Invokamet?

Invokamet is a type-2 diabetes medication containing canagliflozin and metformin, manufactured by Janssen Pharmaceuticals, a subsidiary of pharmaceutical giant Johnson & Johnson. An extended-release version of the drug, Invokamet XR, is also available. When used with diet and exercise, the medication is approved to treat high blood sugar and improve blood sugar control in people with type-2 diabetes.

Invokamet is in the diabetes medication class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. These drugs reduce the reabsorption of glucose in the kidneys which allow excess glucose to be excreted through urine. The metformin portion of the drug is a tried and true method for improving glucose tolerance in diabetic patients.

There are a number of other SGLT2 inhibitor drugs approved for use in the U.S., including Farxiga (dapagliflozin), Jardiance (empagliflozin), and Invokana (canagliflozin).

Is Invokamet Safe?

Invokamet is associated with a variety of adverse side effects ranging in severity. While any medication comes with certain risks, Invokamet has been linked with serious complications — some of which consumers claim they were not adequately warned about. The most severe side effects include Fournier’s gangrene, lactic acidosis, and lower leg amputation.

A study of Invokamet and diabetes ketoacidosis, it appears that patients who take the diabetes drug may be twice as likely to develop the condition as patients who take a different diabetes treatment drug. The drug interferes with the hormone glucagon, which can lead to the body producing dangerously high levels of blood acids called ketones. The condition can be serious and lead to death or coma.

In May 2017, the U.S. Food and Drug Administration (FDA) released a safety announcement that canagliflozin was associated with an increased risk of leg and foot amputation. The announcement included Invokamet, Invokamet XR, and Invokana, a similar drug containing only canagliflozin.

“Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations,” the safety warning read, in part.

The announcement was prompted by the results of two clinical studies – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) trials. These trials aimed to determine canagliflozin’s effect on diabetic heart health but reportedly showed surprising results in terms of diabetic amputation risks.

The CANVAS trial showed that 5.9 out of every 1,000 canagliflozin patients needed an amputation over the course of a year. This was compared to control results of 2.8 out of every 1,000 placebo patients needing an amputation.

The CANVAS-R trial showed similar results with 7.5 out of every 1,000 canagliflozin patients needing an amputation over the course of a year. In comparison, the placebo group saw only 4.2 out of every 1,000 patients needing an amputation.

As a result of the study results, the FDA required new warnings for the diabetes medication – including the agency’s most prominent boxed warning. “We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk,” the FDA stated in their safety announcement.

According to the FDA, patients should not be prescribed canagliflozin if they are predisposed for amputations. This includes patients who have peripheral vascular disease, neuropathy, diabetic foot ulcers, or have had a previous amputation.

Unfortunately, diabetic patients are already at risk of needing a foot amputation. Issues with circulation, nerve damage, and decreased wound healing can increase the chance of a patient developing diabetic foot ulcers. If these sores are left untreated or become infected, a diabetic patient may need part of their foot amputated. In serious cases, the entire foot or even part of the leg may need to be amputated.

There is anout a 25 percent risk of someone with diabetes developing a foot ulcer. Approximately 73,000 lower limb amputations are performed on diabetics in the U.S. every year. For 85 percent of these amputations, a foot ulcer was the underlying reason for the amputation. Some research indicates that up to 50 percent of diabetics who require an amputation will die within two years. Serious risks like this are why people with diabetes may be wary of taking a drug linked to an increased risk of amputation.

Lawsuits have been filed against the drug’s manufacturer, alleging that they were not sufficiently warned of the risks associated with Invokamet.

In fact, the FDA has so far issued six separate Safety Communications over the last five years about serious risks linked with SGLT2 inhibitor medications like Invokamet.

Filing an Invokamet Lawsuit

Patients have taken legal action against the drug’s manufacturer, arguing that they were not sufficiently warned of the risks associated with Invokamet. Plaintiffs allege that manufacturers failed to warn the public and the medical community about the amputation risk and other serious side effects of canagliflozin drugs like Invokamet. As of April 2019, nearly 1,000 lawsuits had been filed over Invokana, along with dozens more over Farxiga.

In addition to those who have lost digits or limbs due to Invokamet, many patients who have developed Fournier’s gangrene have also filed lawsuits against drug manufacturers. Fournier’s gangrene is a dangerous and potentially deadly infection of the genitals with necrotizing fasciitis or flesh-eating bacteria.

The condition is believed to be linked to the use of SGLT2 drugs due to the way these drugs remove sugar from the body. As SGLT2 inhibitors filter sugar from the body through the urine, people taking this type of medication may be more prone to Fournier’s gangrene or other genital conditions including yeast infections.

If you or someone you love has suffered from Invokamet side effects, such as amputation, you may be able to file a lawsuit and pursue compensation.

Filing a lawsuit can be a daunting prospect, especially while dealing with these serious health complications, so Top Class Actions has laid the groundwork by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.

Contact an experienced Invokana attorney today to discuss your legal options if you or a loved one had to undergo a lower limb amputation after taking Invokana, Invokamet or Invokamet XR, including a toe amputation, foot amputation, knee amputation or leg amputation. Fill out the form on this page to obtain a FREE case evaluation with an Invokana amputation attorney.

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