FDANews
The QMN Weekly Bulletin

FDA Adds Additional Warning Labels to SGLT2 Diabetes Inhibitors

Feb. 12, 2016

Following a safety review, the FDA has added additional warnings to the labels of SGLT2 inhibitors for diabetes because they can cause the body to produce too much acid in the blood or lead to serious urinary tract infections.

The new warnings and precautions added to the labels of all sodium-glucose cotransporter-2 inhibitors provide prescribing and monitoring recommendations, the agency says in a safety alert.

Labeling will include warnings to watch for symptoms of ketoacidosis, which include nausea, vomiting, abdominal pain, unusual tiredness and trouble breathing. If any of those symptoms occur while taking an SGLT2 inhibitor, patients are instructed to stop taking the medicine and seek medical attention immediately.

Additionally, patients should be on the lookout for serious UTIs, and contact their healthcare professionals if they have symptoms such as a burning feeling when urinating, a need to urinate often or right away, blood in the urine or pain in the pelvis area, the FDA says.

The FDA also is requiring manufacturers of SGLT2 inhibitors to conduct postmarketing studies.

Drugs in this class include Janssen’s Invokana and Invokamet, Bristol-Meyers Squibb and AstraZeneca’s Farxiga, AstraZeneca’s Xigduo XR, and Boehringer Ingelheim’s Jardiance and Glyxambi.

The safety review commenced in May, when the agency issued a drug safety communication warning of the risk of ketoacidosis, adding that it would continue to evaluate the issue.

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