SGLT2 Inhibitors and ketoacidosis: Warnings about too much acid in the blood and serious urinary tract infections included in new drug labels

Last Updated on

December 5, 2015 – A safety review by the American Food and Drug Administration (FDA) has resulted in the addition of specific warnings to the drug 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.

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. Ketoacidosis IMedicines in the SGLT2 inhibitor class include Canagliflozin (Invokana),  Canagliflozin / Metformin (Invokamet), Dapagliflozin (Farxiga), Dapaglifloxin / Metformin (Xigduo), Empagliflozin (Jardiance), Empagliflozin / Metformin (Synjardi), and Empagliflozin / Linagliptin (Glyxambi).

Already in May 2015, the FDA had issued a drug safety communication warning about the risk of ketoacidosis with SGLT2 inhibitors and alerting that the agency would continue to evaluate this potentially serious safety issue. In doing so, 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. Thasso post had a report on the issue at the time.

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.

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 by completing and submitting the report online at: www.fda.gov/MedWatch/report

Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm475553.htm

Tags: , , , , , , , , , , , , , ,
About the Author
Joseph Gut - thasso Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.
1 Pings/Trackbacks for "SGLT2 Inhibitors and ketoacidosis: Warnings about too much acid in the blood and serious urinary tract infections included in new drug labels"

Your opinion

Comment

No comments yet

thasso: conditions

thasso: newest tweets

thasso: recent comments

thasso post: magazine

View my Flipboard Magazine.

thasso: categories

thasso: archives

thasso: simple chat

You must be a registered user to participate in this chat.

  • Study of rare genetic disorder that effects the eyes April 3, 2020
    Nagano prefecture is home to a group of people affected with a rare genetic neurodegenerative disorder called familial amyloid polyneuropathies (FAP). This disease impacts the gene encoding protein transthyretin (TTR) which is produced in the liver and also eyes. Liver transplants are often a treatment for this disease, but severe eyesight problems such as cloudiness […]
  • Natural sunscreen gene influences how we make vitamin D April 2, 2020
    Genetic variations in the skin can create a natural sunscreen, according to University of Queensland researchers investigating the genes linked with vitamin D.
  • Single mutation leads to big effects in autism-related gene April 2, 2020
    A new study in Neuron offers clues to why autism spectrum disorder (ASD) is more common in boys than in girls. National Institutes of Health scientists found that a single amino acid change in the NLGN4 gene, which has been linked to autism symptoms, may drive this difference in some cases. The study was conducted […]
  • Lifestyle changes could delay memory problems in old age, depending on our genes April 2, 2020
    Researchers from King's College London have shown that how we respond to changes in nutrients at a molecular level plays an important role in the aging process, and this is directed by some key genetic mechanisms.
  • Geneticists are bringing personal medicine closer for multiracial individuals April 2, 2020
    A new study in Nature Communications proposes a method to extend polygenic scores, the estimate of genetic risk factors and a cornerstone of the personalized medicine revolution, to individuals with multiple ancestral origins. The study was led by Dr. Davide Marnetto from the Institute of Genomics of the University of Tartu, Estonia and coordinated by […]
  • Study of rare genetic disorder that effects the eyes April 3, 2020
    Small gauge vitrectomy for vitreous amyloidosis and subsequent management of secondary glaucoma in patients with hereditary transthyretin amyloidosis.
  • Tissue dynamics provide clues to human disease April 3, 2020
    Scientists in EMBL Barcelona's Ebisuya group, with collaborators from RIKEN, Kyoto University, and Meijo Hospital in Nagoya, Japan, have studied oscillating patterns of gene expression, coordinated across time and space within a tissue grown in vitro, to explore the molecular causes of a rare human hereditary disease known as spondylocostal dysostosis. Their results are published […]
  • Coronavirus: Virological findings from patients treated in a Munich hospital April 3, 2020
    In early February, research teams from Charité - Universitätsmedizin Berlin, München Klinik Schwabing and the Bundeswehr Institute of Microbiology published initial findings describing the efficient transmission of SARS-CoV-2. The researchers' detailed report on the clinical course and treatment of Germany's first group of COVID-19 patients has now been published in Nature*. Criteria may now be […]
  • Case study: Treating COVID-19 in a patient with multiple myeloma April 3, 2020
    A case study of a patient in Wuhan, China, suggests that the immunosuppressant tocilizumab may be an effective COVID-19 treatment for very ill patients who also have multiple myeloma and other blood cancers. The report, published in Blood Advances, also suggests that blood cancer patients may have atypical COVID-19 symptoms.
  • Indigenous American ancestry may be associated with HER2-positive breast cancer April 3, 2020
    An increased proportion of Indigenous American (IA) ancestry was associated with a greater incidence of HER2-positive breast cancer, according to a study published in Cancer Research, a journal of the American Association for Cancer Research.
Top