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Invokana™, Farxiga™ and Other Diabetes Drugs (SGLT2 inhibitors)

FDA Identifies the Risk of Acid in the Blood

Sodium-glucose cotransporter-2 (SGLT2) inhibitors such as Invokana™, Farxiga™,  Xigduo™, Jardiance™, and Glyxambi™, have been linked to a number of injurious side-effects in patients taking them for control or maintenance of their diabetes.

What are SGLT2 inhibitors prescribed for?

Invokana™ and other SGLT2 inhibitors are used, in addition to diet and exercise, to control the symptoms of type 2 diabetes.

What is known about the risks of these drugs?

There are a number of side-effects that patients prescribed SGLT2 drugs are at increased risk for.  These include heart attacks, kidney damage, as well as ketoacidosis.  Ketoacidosis is a medical condition where high levels of ketones are produced in the body and enter the blood stream.  These ketones are formed by the breakdown of fatty acids.  The blood can become extremely acidic due to the presence of the acetoacetic acid and the pH of the bloodstream lowered.  In extreme cases, ketoacidosis can lead to death.  Ketoacidosis can be detected on a person’s breath due to the presence of acetone, commonly associated with the odor of nail polish remover.

What should you do if you are currently being treated with one of these drugs?

 If you are currently taking one of these drugs you should pay close attention to heart and kidney health as well as any signs of ketoacidosis.  Talk to your doctor about the risks presented by these drugs and about any signs or symptoms of side effects that you may have so that you and your doctor can make the appropriate risk-benefit assessment in determining the appropriate care.

What has the FDA said about the risk of ketoacidosis?

 The FDA has been paying close attention to the risks of adverse events associated with these drugs.  The FDA recently sent out the following warning regarding these risks:

SGLT2 Inhibitors: Drug Safety Communication – Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections

AUDIENCE: Pharmacy, Emergency Medicine

ISSUE: An FDA safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization.

FDA issued a Drug Safety Communication in May 2015 warning about the risk of ketoacidosis with SGLT2 inhibitors and alerting that the Agency would continue to evaluate this safety issue. A review of the FDA Adverse Event Reporting System (FAERS) database from March 2013 to May 2015 identified 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors (see the Drug Safety Communication Data Summary). Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.

FDA also identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors reported to FAERS from March 2013 through October 2014. All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.

As a result, 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. FDA is also requiring manufacturers of SGLT2 inhibitors to conduct a required postmarketing study. This required enhanced pharmacovigilance study requests that manufacturers perform analyses of spontaneous postmarketing reports of ketoacidosis in patients treated with SGLT2 inhibitors, including specialized follow-up to collect additional information, for a period of 5 years.

BACKGROUND: SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, and empagliflozin.

RECOMMENDATION: Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis.

Health care professionals should assess for ketoacidosis and urinary tract infections in patients taking SGLT2 inhibitors who present with suggestive symptoms. Ketoacidosis associated with the use of SGLT2 inhibitors can occur even if the blood sugar level is not very high. If ketoacidosis is suspected, the SGLT2 inhibitor should be discontinued and treatment instituted promptly.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

The FDA’s warning can be found here.  The FDA is also taking steps to update the labels for these drugs in order to educate patients and doctors about these risks.

If you or a friend or family member has been injured by taking Invokana™ or another SGLT2 inhibitor please contact us using the form below for a free consultation.  Thank you.

 

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Invokana™ is trademark of Janssen Pharmaceuticals, Inc.

Farxiga™ is a trademark of the AstraZeneca Group of companies.

Xigduo™ is a trademark of the AstraZeneca Group of companies.

Jardiance™ is a trademark of Boehringer Ingelheim.

Glyxambi™ is a trademark of Boehringer Ingelheim.

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