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Conference to Review Possible SGLT2 Inhibitor Side Effects

SGLT2 Inhibitor pillsA leading professional organization devoted to the care and treatment of diabetes patients has announced a conference convened to review ketoacidosis as one of a handful of possible SGLT2 inhibitor side effects.   The American Association of Clinical Endocrinologists (AACE) announced plans for the conference on June 29 after receiving questions from its membership about the potentially deadly side effect that has been linked to a new class of diabetes type 2 medications.

The organization’s president, George Grunberger, MD, FACP, FACE, stated in the announcement that “AACE’s responsibility to its members and their diabetes patients is to conduct a complete, objective and balanced evaluation of the data and investigate any knowledge gaps before issuing our recommendations. He added that, “There are still unanswered questions to answer before we draw any definitive conclusions on the subject, and that is what this conference is designed to do.” The conference (AACE/ACE Scientific and Clinical Review of DKA and The Effects of SGLT2 Inhibitors) has been set for October 24-25, 2015 at the Grand Hyatt DFW in Dallas, TX.

SGLT2 inhibitors topic of FDA safety communication

The FDA issued a safety communication about diabetic ketoacidosis as a potential SGLT2 inhibitor side effect on May 15, announcing that there had been 20 adverse event reports among those using the diabetes type 2 drugs (including Invokana, or canagliflozin, produced by Johnson & Johnson and approved in March of 2013, and Farxiga, or dapagliflozin, produced by AstraZeneca, and approved in January of 2014) between March 2013 and June 6, 2014. They have received additional reports since that time.

The agency stressed that further review of a possible link between the use of SGLT2 inhibitors and ketoacidosis is necessary, but cautioned that type 2 diabetes patients taking the drugs such seek prompt medical attention if they experience symptoms of the condition, including difficulty breathing, nausea, vomiting, abdominal pain, confusion, unexplained fatigue or drowsiness, or sweet-smelling breath. Ketoacidosis is a condition in which acid (ketones) build up to dangerous levels in the blood. If not treated, it can result in dehydration, loss of consciousness, coma and, eventually, death.

Farxiga and Invokana litigation on the horizon

Whereas older diabetes type 2 drugs tended to work by altering the functioning of insulin, the new medications work by causing the kidney to pass large amounts of glucose in the urine rather than putting it into circulation in the blood. The Institute for Safe Medication Practices (ISMP) has noted that kidney failure and other kidney problems are among the 457 serious adverse event reports discussed in their May 21 quarterly report in connection to SGLT2 inhibitors. In addition, some experts believe that the medications were not assessed properly in connection to potential heart problems during the initial approval process.

Public Citizen, a public safety watchdog group, expressed doubt about the safety of the new class of medications as early as 2013, opining that the manufacturers had conducted insufficient safety trials prior to the drugs approval and suggesting that advertising noting “potential weight loss” may have been misleading. Some legal experts believe that Farxiga and Invokana lawsuits may be on the horizon.