Invokana Side Effects

A new class of medications designed to treat type 2 diabetes, SGLT2 inhibitors came to the market over the past few years to great fanfare. The drugs work by altering normal kidney function by prompting excess glucose to leave the body through urine rather than making its way into the blood stream. This mechanism differs significantly from other diabetes medications, which address insulin availability as a means to control blood glucose.

The first version of these drugs to come to market was Invokana, and it gained rapid popularity, with hundreds of thousands of prescriptions written in the year following its release. It and other SGLT2 inhibitors also attracted positive attention due to the fact that in many patients, they produced moderate amounts of weight loss and a lowering of their blood pressure.

Other medications in this class that have reached the market since Invokana include:

• Farxiga (dapagliflozin)
• Jardiance (embagliflozin)
• Xigduo XR (a combination drug comprised of dapagliflozin and metformin)
• Invokamet (canagliflozin and metformin hydrochloride)
• Glyxambi (empagliflozin and linagliptin)

Reports of SGLT2 side effects begin to grow

Not long after their debut on the market, SGLT2 drugs have been the subject of reports concerning potentially serious side effects that have included:

• Diabetic ketoacidosis
• Cardiovascular events
• Kidney malfunction
• Stroke
• Coma
• Fatalities

There have also been reports of comparatively less severe side effects resulting from the use of SGLT2 diabetes drugs, such as:

• Urinary tract infections
• Swelling of the face and mouth
• Skin rashes
• Lightheadedness
• Dehydration
• Yeast infections
• Boost in LDL (“bad) cholesterol

Understanding the danger of ketoacidosis

Perhaps the most alarming of the side effects reported in connection to SGLT2 inhibitors is that of diabetic ketoacidosis. When this condition presents itself, the body begins to produce excessive amounts of acids (ketones) that are then released into the blood. Such individuals may lapse into a coma or suffer death. The appearance of this condition in patients with type 2 diabetes is unusual, as it is something that typically only impacts type 1 patients who have had blood glucose spikes.

Because type 2 patients suffering from ketoacidosis do not typically exhibit a significant blood sugar spike, it is important for them to remain mindful of symptoms such as thirst, unusual urge to urinate, vomiting, nausea, abdominal discomfort and breathing trouble.

FDA issues safety communication

On May 15, 2015, the U.S. Food and Drug Administration issued a safety communication alerting the public to the existence of a growing number of adverse event reports concerning the use of SGLT2 inhibitors and cases of ketoacidosis. The patients who were the subjects of these reports had all been hospitalized or had visited the emergency room for urgent treatment of the condition. As a result the agency plans to carefully monitor all further reporting and urges those who experience such complications to report them promptly.

The FDA also urges those taking this class of medication to remain vigilant about the warning signs of ketoacidosis and seek treatment as soon as possible following their appearance, as such action greatly increases the likelihood of a positive outcome.

SGLT2 inhibitors and risk of heart attack

Though studies have produced conflicting results, there has been concern that SGLT2 inhibitors may also be linked to cardiovascular side effects in patients with type 2 diabetes. Following Invokana’s approval in 2013, the FDA instructed its manufacturer, Johnson & Johnson, to perform a series of post-market studies to learn more.

One such study seemed to indicate the existence of elevated heart attack and stroke risk during the first 30 days of a patient starting the drug, though that risk appeared to diminish over time. Some observers believe that post-market research on these drugs has not yet been substantial enough to offer a comprehensive assessment of their risks and others have expressed concern that the labeling of Invokana includes no language discussing possible risks of stroke or heart attack.

Reports of elevated risk of kidney failure

Alarms have also been sounded about Invokana as a possible cause of kidney failure in type 2 diabetes patients using it as a means to manage excess blood glucose. A recent report issued by the Institute for Safe Medication Practices cited over 450 adverse event reports related to Invokana, with many of those concerning complications connected to kidney function.

Fluid imbalances, dehydration, kidney stones, kidney impairment, urinary tract infections and kidney failure in patients using Invokana have led to real concern about the impact of the drug’s distinct glucose elimination mechanism on overall kidney health and function.

Concern over Invokana side effects persists

With type 2 diabetes thought by many to be one of the most problematic health concerns facing our population, it is easy to understand why SGLT2 inhibitors such as Invokana were brought to market with such excitement and optimism. However, recent concerns about the safety of these medications and the emergence of substantial numbers of adverse event reports pertaining to their use has served to temper that enthusiasm. Physicians and patients everywhere will need to determine whether the promised benefits of these new-generation diabetes drugs outweigh what many believe are the very real risks of ketoacidosis and other serious complications they present.

The FDA’s pledge of ongoing review and scrutiny of these drugs in the coming months and years will likely assist them in that process.

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