Safety Alerts & Recalls

What does this mean?

Medications from the class of SGLT2 inhibitors are used together with diet and exercise to treat type 2 diabetes. If left untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. Therefore, the benefit of treatment with an SGLT2 inhibitor will usually continue to outweigh the risk for most patients. The new side effect of ketoacidosis is very rare and was only detected now that these medications are in widespread use.

Please learn the early symptoms of ketoacidosis. Should you experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness, seek medical help immediately, as these could be early signs of ketoacidosis.

If you are taking a medication containing empagliflozin (Jardiance, Glyxambi), dapagliflozin (Farxiga, Xigduo XR), and canagliflozin (Invokana, Invokamet) and are worried about this information, talk to your doctor about it. However, do not stop taking the medication on your own.

If you have further questions about this safety alert or any of your medications, please follow up with your doctor.

Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: http://www.fda.gov/Safety/MedWatch/default.htm

FDA Warns About Possible New Side Effect of SGLT2 Inhibitors

In a recent safety announcement, the U.S. Food and Drug Administration (FDA) warned about possible ketoacidosis caused by the class of type 2 diabetes medications called sodium-glucose cotransporter-2 (SGLT2) inhibitors. These include the medications containing empagliflozin (Jardiance, Glyxambi), dapagliflozin (Farxiga, Xigduo XR), and canagliflozin (Invokana, Invokamet). Ketoacidosis is a serious condition in which the body produces high levels of blood acids called ketones that may require hospitalization. The FDA is continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of medications.

Until now it was not known that SGLT2 inhibitors could trigger ketoacidosis and this information is not found in the product information. SGLT2 inhibitors are approved for the treatment of type 2 diabetes. Patients with type 2 diabetes are usually not at risk for developing spontaneous ketoacidosis and may not recognize the early symptoms. The FDA is advising doctors to inform their patients about ketoacidosis and its symptoms.

For more information, please visit: more information here

Source: FDA
Publication Date: 2015-05-27
Last Updated: 2015-05-27
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