FDA Warnings and Lawsuits: Diabetes Medications Cause Leg Amputations, Kidney Damage, Ketoacidosis and Serious Urinary Tract Infections - Invokana, Invokamet, Invokamet XR (canagliflozin)

Posted on behalf of Arnold Law Firm on May 30, 2017 in Class Action Lawsuits

FDA communication foot and leg amputationThe Arnold Law Firm is accepting cases and vigorously representing clients injured by diabetes medications containing the drug canagliflozin. This includes the brand names Invokana, Invokamet and Invokamet XR. The drug can cause circulation problems leading to leg amputations, kidney failure and a life-threatening change in the blood known as ketoacidosis.

In May of 2017, the United States Food and Drug Administration (FDA) confirmed that Invokana (canagliflozin) “causes an increased risk of leg and foot amputations.” A year before, the FDA had warned the medical community that it saw links between the medication and amputations. It has now made that finding formal and ordered that the medication include a black-box warning.

Even before this warning on leg amputations, Invokana drugs were found to be linked to kidney damage and ketoacidosis. This has resulted in a wave of lawsuits by patients who suffered life-changing injuries from a medicine that was supposed to control their diabetic symptoms – not make them worse.

What is Invokana (Canagliflozin) and How Does it Work?

Invokana is a medication used to treat type 2 diabetes over the long-term. In diabetes, a patient’s blood sugar rises to unhealthy levels. Many medications that treat diabetes work by pushing the sugar out of the blood. Traditional insulin therapy works by pushing sugar from the blood into cells. This lowers blood sugar, which is good for the short term. However, over time, cells can die or malfunction due to having been forced to take in so much sugar. The body tries to prevent this from happening by becoming more resistant to the effects of insulin, leading to a cycle of increasing doses of insulin, increased resistance and increased storage of sugar in cells where it does not belong. This cycle can lead to tissue death, metabolic problems, nerve pain and a host of other complications.

Invokana seeks to avoid these problems by causing excess sugar to be excreted in urine. Theoretically, if sugar is eliminated from the body, it cannot build up in the cells or the blood. To make this happen, Invokana changes the way the kidneys filter blood.

SGLT2 Inhibitors infographicOrdinarily, kidneys filter blood in multiple stages. Taken together, these stages result in toxins being removed from the blood and sent out via urine. Other substances that are needed are retained.

One of the stages of normal kidney filtration removes sugar from the blood as part of a larger process. Another stage “fixes” the kidney’s removal of sugar and puts it back into the blood. This process of replacing the sugar uses a naturally occurring substance called SGLT2 (sodium-glucose co-transporter 2).

Invokana inhibits SGLT2. As a result, the kidney does not put as much sugar back into the blood. Excess sugar is excreted through urine, resulting in lower blood sugar without all the problems associated with long-term insulin therapy.

Why Are People Suing About Invokana (Canagliflozin)?

Invokana sounds like a really good drug, in theory. However, the body is a very complex system, and changing one thing, like SGLT2, can cause a host of other changes. Drugs can also have unintended effects on systems other than the one they are prescribed for. That is why it is so important for patients and doctors to know all the risks of a drug. You cannot plan for your health if you are taking drugs with side-effects that you are not told about.

Knowing about side effects becomes even more important if you receive a prescription “off-label.” This is when your doctor prescribes a medicine to treat something other than what it was approved for by the FDA. Lawsuits allege that the makers of Invokana marketed doctors to encourage them to use the drug to treat conditions it was not approved for, including weight loss, reduced blood pressure and treatment of patients with type 1 diabetes. Taking a drug off-label can be risky. It becomes much riskier if the drug maker is not open about side effects.

Even if taken as approved, Invokana can cause three major problems in some patients. These are serious enough to cause death or profound injury:

1. Kidney Damage

FDA strengthens kidney warningsPatients who are prescribed Invokana are already in a group of patients, diabetics, who are often at risk for kidney problems. Unfortunately, Invokana causes some patients acute kidney injury, often within the first months of use. Signs of acute injury from Invokana can include decreased urination and swelling, especially in the legs and feet.

Some injured patients will need dialysis. Stopping use of the medicine, after getting the advice of a physician, can help many patients.

The FDA released a warning about kidney damage in June 2016. The FDA gave cautionary advice to physicians and suggested that patients report side effects of Invokana to the FDA MedWatch program.

 

2. Ketoacidosis and Urinary Tract Infections

Ketoacidosis is a serious and potentially life-threatening complication of diabetes. In ketoacidosis, blood levels of ketones become very high. This turns the blood acidic.

Ketones are molecules that can be used by the body for energy. Although we often speak of having energy in terms of “blood sugar,” the body also can burn fat. When fat is metabolized, it is converted into ketones, not blood sugar. Ketones are carried to the cells, where mitochondria burn them for fuel. Mitochondria also burn glucose for fuel.

Broadly speaking, the body will burn blood sugar before ketones. Since so many common foods convert into blood sugar, many people burn little to no ketones on a regular basis. This can complicate things if the body suddenly believes it does not have enough blood sugar. One way the body can react to low blood sugar is to create ketones as a backup power supply. However, if the body is not “adapted” to ketones yet, many of the ketones are not useable as fuel and must be excreted through urination. If a patient has a compromised kidney, it can be hard to eliminate the ketones, causing them to build up in the blood.

FDA warning urinary tract infectionsKetoacidosis in Invokana patients is especially dangerous due to difficulty in diagnosing it. Frequently, ketoacidosis is diagnosed when a blood sample shows both high glucose and high ketones. However, Invokana patients can have low blood sugar even with high ketones. The FDA warns that this can lead to delays in diagnosis and treatment, posing a danger to patients.

The FDA cautioned, “Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis.”

At the same time, the FDA also warned patients that Invokana can cause serious urinary tract infections. Patients were encouraged to be on the watch for symptoms such as a feeling of burning when urinating or the need to urinate often or right away; pain in the lower part of the stomach area or pelvis; fever; or blood in the urine.

3. Amputations of Legs, Feet or Toes

FDA amputations warningIn May of 2016, the FDA warned that Invokana “causes” diabetes complications that result in amputation of legs and feet at about double the normal rate for patients with diabetes. The FDA stated, “Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.”

Patients should speak to their physicians immediately if they develop new pain or tenderness, sores or ulcers, or infections in the legs or feet. These can be signs of Invokana-related complications that could lead to amputation.

What Can Patients Do?

From a medical standpoint, talk to your physician. You may want to explore newer information indicating that special diet-based changes have the potential to substantially reduce the effects of diabetes. Physicians in the United States and Canada have used medically controlled fasting to make great strides in diabetes treatment without relying on drugs like insulin and Invokana. At some point, patients may be able to cure or manage type 2 diabetes without any medications. Consider for instance a recent patent to USC researchers for a diet and fasting protocol that may “reverse” diabetes.

From a legal standpoint, if you or a loved one is a patient affected by these kinds of complications, please call us at the Arnold Law Firm. We would be happy to discuss how your case may fit into ongoing litigation. You may be entitled to compensation for your injuries. There is no charge for our initial consultation, and all work is done on a contingency basis. Lawsuits about dangerous drugs or ineffective drug warnings help improve the practice of medicine and can help restore dignity and security to affected patients and their families.

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