{"id":38540,"date":"2015-12-07T10:19:00","date_gmt":"2015-12-07T15:19:00","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&#038;p=38540"},"modified":"2015-12-28T09:21:54","modified_gmt":"2015-12-28T14:21:54","slug":"fda-revises-labels-of-sglt2-inhibitors","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=38540","title":{"rendered":"FDA Revises Labels of SGLT2 Inhibitors"},"content":{"rendered":"<p class=\"p1\" style=\"text-align: justify;\"><span class=\"s1\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/06\/FDA-large-logo.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft wp-image-37955 lazyload\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/06\/FDA-large-logo.jpg\" alt=\"FDA large logo\" width=\"200\" height=\"133\" data-sizes=\"auto\" data-srcset=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/06\/FDA-large-logo.jpg 600w, https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/06\/FDA-large-logo-300x200.jpg 300w\" sizes=\"(max-width: 200px) 100vw, 200px\" \/><\/a>A U.S. 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 (such as Invokana,\u00a0<\/span><span class=\"s2\">Farxiga and\u00a0Jardiance)<\/span><span class=\"s1\">\u00a0about the risks of too much acid in the blood and of serious urinary tract infections.\u00a0 Both conditions can result in hospitalization.<\/span><\/p>\n<p class=\"p1\" style=\"text-align: justify;\"><span class=\"s1\">Patients should\u00a0<b>stop taking their SGLT2 inhibitor and<\/b>\u00a0<b>seek medical attention immediately<\/b>\u00a0if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones.\u00a0 Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.\u00a0 Patients should also be alert for signs and symptoms of a\u00a0<a href=\"http:\/\/www.niddk.nih.gov\/health-information\/health-topics\/Anatomy\/urinary-tract-how-it-works\/Pages\/anatomy.aspx\"><span class=\"s3\">urinary tract<\/span><\/a>\u00a0infection, such as a feeling of burning when urinating or the need to urinate often or right away; pain in the lower part of the stomach area or pelvis; fever; or blood in the urine.\u00a0 Contact a health care professional if you experience any of these symptoms.<\/span><\/p>\n<p class=\"p1\" style=\"text-align: justify;\"><span class=\"s1\">Health care professionals should assess for ketoacidosis and urinary tract infections in patients taking SGLT2 inhibitors who present with suggestive symptoms.\u00a0 Ketoacidosis associated with the use of SGLT2 inhibitors can occur even if the blood sugar level is not very high.\u00a0 If ketoacidosis is suspected, the SGLT2 inhibitor should be discontinued and treatment instituted promptly.<\/span><\/p>\n<p class=\"p1\" style=\"text-align: justify;\"><span class=\"s1\">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.\u00a0 When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.\u00a0 Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, and empagliflozin (see section on List of FDA-approved SGLT2 Inhibitors for Type 2 Diabetes).\u00a0 SGLT2 inhibitors are not FDA-approved for use in patients with type 1 diabetes.<\/span><\/p>\n<p class=\"p1\" style=\"text-align: justify;\"><span class=\"s1\">The FDA issued a\u00a0<a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm446845.htm\"><span class=\"s4\">Drug Safety Communication<\/span><\/a>\u00a0in May 2015 warning about the risk of\u00a0<a href=\"https:\/\/asweetlife.org\/feature\/do-sglt2-inhibitors-like-invokana-cause-ketoacidosis\/\"><span class=\"s3\">ketoacidosis with SGLT2 inhibitors<\/span><\/a>\u00a0and alerting that they\u00a0would continue to evaluate this safety issue.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A U.S. 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 (such as Invokana, Farxiga and Jardiance) about the risks of too much acid in the blood and of serious urinary tract infections.  Both conditions can result in hospitalization.<\/p>\n","protected":false},"author":131,"featured_media":37955,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1442],"tags":[1291,358],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Revises Labels of SGLT2 Inhibitors<\/title>\n<meta name=\"description\" content=\"The FDA is adding warnings to the labels of a specific class of type 2 diabetes medicines 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