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On May 15, 2015, the FDA issued a drug safety communication notifying healthcare providers and diabetes patients that type 2 diabetes drugs like Invokana could increase the risk of diabetic ketoacidosis. (DKA). This is a very serious condition in which the blood becomes too acidic. Without immediate treatment, DKA can result in a diabetic coma and even death.

The FDA based their warning on 20 reports of patients with type 2 diabetes who were taking drugs like Invokana and developed DKA. All of these patients required hospitalization for the condition. The FDA indicated they have continued to receive similar reports since that time, and urged doctors and patients to report future incidences to the FDA MedWatch program.

Invokana Linked with Reports of Serious Side Effects

Invokana (canagliflozin) belongs to a class of drugs known as SGLT2 inhibitors. These drugs work to lower blood sugar levels by causing the kidneys to remove some glucose from the body via the urine.

The FDA approved the drug for the treatment of type 2 diabetes in 2013. Within just a year, however, Invokana was linked with 457 reports of problems, including kidney failure or impairment, dehydration and fluid imbalances, kidney stones, and urinary tract infections.

Type 2 Diabetes Patients Hospitalized with Invokana DKA

DKA is a condition that is more common in patients with type 1 diabetes. These patients often lack sufficient insulin to process glucose, so their bodies break down fat for fuel instead. This process produces by-products called “ketones.”

In most cases, the kidneys flush away excess ketones in the urine. Patients with type 1 diabetes, however, may have unused glucose in the blood as well, raising blood sugar levels. High blood sugar and high levels of ketones together are symptoms of diabetic ketoacidosis (DKA).

Strangely, the 20 cases that drew the FDA’s attention occurred in type 2 diabetes patients who had only slightly elevated blood sugar levels. Researchers now theorize that the drug’s affect on the kidneys may have something to do with these cases, but so far, we don’t know exactly what’s causing DKA in some people who take Invokana.

Invokana DKA a Potentially Fatal Crisis

DKA is a rare but potentially fatal crisis in diabetes patients. According to a recent study, it caused 140,000 hospitalizations in 2009, with an average length of stay of 3.4 days. The most common cause is the omission of insulin—the patient forgets his injection or otherwise fails to take it. Other causes may include infections, heart attacks, strokes, stomach bleeding, Cushing’s syndrome, and recent surgical procedures.

Medications, however, can also increase risk of the condition. Researchers already know that diuretics, beta-blockers, corticosteroids, antipsychotics and anticonvulsants can all affect carbohydrate metabolism, which can bring on DKA. Only recently have researchers began to recognize that patients with type 2 diabetes can also suffer DKA, but in most cases, they are obese or extremely insulin resistant.

These cases that were reported to the FDA represent a new concern, as so far, it’s not typical to worry about DKA in type 2 diabetes patients taking anti-diabetic medications. Doctors and patients are wise to be on the alert for early symptoms, which may include excessive thirst, dry mouth, frequent urination, high blood sugar levels, and high levels of ketones in the urine.

More serious symptoms requiring immediate medical attention include difficulty breathing, nausea and vomiting, abdominal pain, confusion, unusual fatigue, dry or flushed skin, and a fruity odor on the breath.

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