Invokana and Invokamet are two of the most popular type-2 diabetes medications, manufactured by Janssen Pharmaceuticals. Unfortunately, despite the popularity of the drugs, they have been associated with some serious side effects.

Indeed, the U.S. Food and Drug Administration (FDA) has warned that Invokana and Invokamet side effects include a nearly doubled risk of leg and foot amputations.

Basics of Invokana and Invokamet

Invokana (canagliflozin) and Invokamet (canagliflozin and metformin hydrochloride) are type-2 diabetes drugs manufactured by Janssen Pharmaceuticals. Janssen also has an extended release version of Invokamet, called Invokamet XR (canagliflozin and metformin hydrochloride extended-release). Invokana is manufactured by Janssen, and was approved by the FDA back in 2013.

Type-2 diabetes is a chronic condition affecting the body’s glucose production, and can lead to more serious issues like blindness, nerve and kidney damage, and even heart disease, according to the Mayo Clinic.

To treat type-2 diabetes, canagliflozin drugs work to lower blood sugar. Canagliflozin belongs to a larger class of drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. Invokana was the first SGLT2 inhibitor approved by the FDA, but was followed shortly thereafter by several others, including Farxiga in 2014.

Invokana and Invokamet Side Effects

Unfortunately, these canagliflozin drugs have been linked with some significant risks, including foot and leg amputations, with the FDA issuing a warning.

The FDA based its warning off of information gathered from two large recent clinical trials. According to P&T Community, the trials, known as CANVAS and CANVAS-R, showed that canagliflozin patients required leg and foot amputations nearly twice as much as those who were treated with a placebo. The CANVAS trial found that 5.9 out of 1,000 patients treated with canagliflozin required amputation, compared with 2.8 out of 1,000 for those taking the placebo.

The CANVAS-R trial resulted in a similar difference—7.5 canagliflozin users faced this side effect, compared with 4.2 out of 1,000 placebo takers. In both cases, the amputation risk was nearly doubled for canagliflozin users.

The most common amputation types for affected patients were toe and middle of the foot. Both above and below the leg amputations also occurred. In some cases, patients required more than one amputation.

In response, the federal agency required that a boxed warning be added to canagliflozin labels detailing this risk.

The FDA has advised those taking canagliflozin to alert their health care professionals immediately if they notice symptoms like new pain, tenderness, sores, ulcers, or infections in their legs or feet.

For Some, FDA Warning Comes Too Late

Despite the FDA’s safety warning and the fact that Invokana drug maker Johnson & Johnson was subsequently required to include a black box warning about the risk of amputation linked with taking Invokana, these measures were too little, too late for some patients.

Indeed, more than 1,000 people who have suffered from lower limb amputations after taking Invokana have filed lawsuits against Johnson & Johnson, along with its subsidiary, Janssen Pharmaceuticals.

As of April 2019, a total of 965 lawsuits had been filed over Invokana injuries, along with 37 lawsuits over Farxiga. Source: https://www.drugwatch.com/sglt2-inhibitors/lawsuits/]

Other major side effects that have been associated with SGLT2 inhibitor drugs include kidney damage, diabetic ketoacidosis, and the flesh-eating disease Fournier’s gangrene. Because of these complications, the FDA has issued a total of six separate Safety Communications warnings in just five years about the serious side effects connected with SGLT2 inhibitors like Invokana and Invokamet.

For those who have suffered from these major side effects before the FDA released its safety warnings, it was too late. Side effects of SGLT2 inhibitors can cause ongoing pain, suffering, loss of quality of life, and significant financial losses. In response, many have turned to litigation, alleging that manufacturers failed to adequately warn them about the risks in time to prevent them.

Filing a Lawsuit Over Invokana or Invokamet Side Effects

Patients may wonder why the manufacturers of these canagliflozin drugs didn’t warn them and the medical community about the amputation risk associated with their medications. It may be that safety trials performed prior to the release of the drug were insufficient, or that the warnings originally provided failed to give adequate warning about the risk.

If it is discovered that the manufacturers either did not conduct proper testing or failed to warn about the risk, they may be held liable for any injuries patients have suffered as a result.

If you or a loved one have suffered from Invokana or Invokamet side effects, such as toe, foot, or leg amputation, after taking one of these SGLT2 inhibitor drugs, you may be able to file a lawsuit and pursue compensation.