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In May of 2015 the FDA issued a Drug Safety Communication about SGLT2 inhibitors in which the FDA warned that taking SGLT2 inhibitors may lead to a serious condition called diabetic ketoacidosis, which may require hospitalization.
On December 4, 2015, the FDA released an updated Drug Safety Communication announcing that after further review, the FDA has determined that additional warnings to the labels of SGLT2 inhibitors are necessary to warn about “the risks of too much acid in the blood and of serious urinary tract infections” associated with this class of drugs, noting that “[b]oth conditions can result in hospitalization.”
The FDA recommended that patients should "stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones."
The FDA recommended that patients should “stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones.” The FDA also warned about life-threatening blood infections (known as urosepsis) and serious kidney infections (known as pyelonephritis) that started as urinary tract infections (UTIs) in patients taking SGLT2 inhibitors.
Because of these serious side effects, the FDA “added new Warnings and Precautions to the labels of all SGLT2 inhibitors to describe these two safety issues, and to provide prescribing and monitoring recommendations.” The FDA is also requiring SGLT2 inhibitor manufacturers to conduct an additional postmarketing study regarding these adverse events.
On May 18, 2016, the FDA released a Drug Safety Communication regarding the SGLT2 inhibitor canagliflozin. Canagliflozin is sold as Invokana and Invokamet. Based on reports from a clinical trial of patients taking the medication, there may be twice as many leg and foot amputations occurring as compared to patients taking a placebo. In Europe, the European Medicines Agency (EMA) is also investigating the validity of the data resulting in this side effect. The majority of the issues appear to be with the need to amputate toes.
What Are SGLT2 Inhibitors?
SGLT2 inhibitors lower blood sugar (glucose) levels by reducing the amount of glucose that is absorbed by the kidneys. The drugs inhibit the ability for the kidneys to recirculate glucose to the body, passing the sugar out of the body through the urine instead.
- Invokana (canagliflozin)
- Invokamet (canagliflozin and metformin)
- Farxiga (dapagliflozin)
- Xigduo XR (dapagliflozin and metformin extended-release)
- Jardiance (empagliflozin)
- Glyxambi (empagliflozin and linagliptin)
SGLT2 Inhibitors May Cause Diabetic Ketoacidosis and Serious Urinary Tract Infections
Diabetic ketoacidosis (DKA) is a serious condition, which, in extreme cases, can result in a diabetic coma or death. DKA most commonly occurs in patients with type 1 diabetes and is usually accompanied by high blood sugar levels. The SGLT2 DKA cases were not typical for DKA because most of the patients had type 2 diabetes, and their blood sugar levels, when reported, were only slightly increased compared to typical cases of DKA.
When a person’s cells don’t get the blood sugar (glucose) needed to create energy because of insufficient insulin available to guide glucose into cells, the body starts to burn fat to create energy. This process produces waste chemicals called ketones, a type of acid.
Your body reacts this way when it doesn’t have enough insulin to allow cells to process glucose, the way a typical, healthy body generates energy. As ketones accumulate in the bloodstream, they make it more acidic. High ketone levels are toxic and can poison the body.
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Symptoms of Diabetic Ketoacidosis
The FDA warning advises patients to pay careful attention for any signs of ketoacidosis and to seek immediate medical attention if you experience symptoms, which include:
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Difficulty breathing
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Nausea or vomiting
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Abdominal pain
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Unusual fatigue or sleepiness
SGLT2 Inhibitors Invokana and Farxiga May Increase Risk for Kidney Injury
Recently, the Canadian regulatory counterpart to the U.S.’s FDA, Health Canada, found after a review of data that the SGLT2 inhibitors available in Canada prior to August 2015, Invokana and Forxiga (known as Farxiga in the U.S.), may carry an increased risk of acute kidney injury.
Type 2 Diabetes Is a Chronic Condition
Type 2 diabetes mellitus (T2DM) is a chronic condition that is characterized by the body’s impaired ability to process glucose (blood sugar) to create energy. The condition used to be known as adult-onset or noninsulin-dependent diabetes, and it is the most common type of diabetes.
With T2DM, a person’s body either doesn’t react to insulin the way a healthy person’s body does or it doesn’t produce enough insulin to keep blood sugar levels stable and in a healthy range.
Insulin is a hormone that assists in digestion to ensure that glucose in the blood enters the body’s cells to create energy. In someone with type 2 diabetes, not enough insulin is produced by the pancreas or cells are not using the insulin as they should and blood sugar is not able to enter a body’s cells to create energy. Instead, the sugar stays in the blood, where it can cause damage and problems in other organs, nerves or parts of the body.
Potential Compensation for DKA or Kidney Failure After Taking SGLT2 Inhibitors
If you have been diagnosed with type 2 diabetes and suffered serious health problems due to diabetic ketoacidosis or kidney failure after taking an SGLT2 inhibitor medication such as Invokana, you may be entitled to compensation.
Depending on your circumstances, you could be reimbursed for the cost of hospitalization and any related medical care, as well as other expenses.
You may also be able to receive compensation for any time you needed to take off from work to deal with your illness.
How Weitz & Luxenberg Can Help
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