On May 15, 2015, the FDA issued a drug safety alert based on data linking the use of certain type-2 diabetes drugs (sodium-glucose-cotransporter-2 (SGLT-2) inhibitors) with ketoacidosis. Ketoacidosis is a serious medical condition, usually requiring hospitalization, in which one’s blood becomes overly saturated with acids known as ketones. Typical symptoms of the condition include nausea, vomiting, trouble breathing, confusion, fatigue, and stomach pain. SGLT-2 inhibitors are sold as stand-alone drugs under the brand names Farxiga, Invokana, and Jardiance and as combination drugs under the brand names Invokamet (used with Metformin), Xigduo XR (used with Metformin Extended Release) and Glyxambi (used with Linagliptin). These drugs have been developed, manufactured and distributed by AstraZeneca, Janssen Pharmaceutical Companies, Eli Lilly and Company and Boehringer Ingelheim. SGLT-2 inhibitors are a newer class of drug used to treat Type-2 diabetes which reduce patients’ blood sugar levels by triggering the kidneys to release excess blood sugar through the urine.
The FDA’s adverse event reporting system, used to gather complaints regarding problematic drugs, medical devices and foods, has received multiple reports of ketoacidosis amongst Type-2 diabetics using SGLT-2 inhibitors, with all reported incidents having required hospitalization. SGLT-2 patients reporting development of ketoacidosis to the FDA typically developed the condition approximately two weeks following the use of an SGLT-2 inhibitor. The linkage between these drugs and ketoacidosis has been particularly apparent to FDA regulators due to the correlation in time between SGLT-2 use and ketoacidosis diagnosis amongst reporting patients and due to the otherwise rarity of this condition amongst Type-2 diabetics.
The FDA, within its alert, has instructed all medical professionals to cease administration of these drugs to Type-2 diabetes patients upon diagnosis of ketoacidosis.
If you or a loved one was diagnosed with ketoacidosis following use of the Type-2 diabetes drugs Farxiga, Invokana, Jardiance, Invokamet, Xigduo XR or Glyxambi, please contact Pope McGlamry at 877.285.7656 or submit a case evaluation online at www.pmkm.com to schedule a complimentary legal consultation. For continued up-to-date information and news regarding SGLT-2 inhibitors and their linkage to ketoacidosis, like the Pope McGlamry page on Facebook, follow us on Twitter @PopeMcGlamry, or visit our website at www.pmkm.com.
