TYPE 2 diabetes drugs — canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance) — may lead to ketoacidosis, the Food and Drug Administration (FDA) warned.
The sodium-glucose co-transporter-2 (SGLT2) inhibitors are designed to lower blood sugar in patients with diabetes, but the FDA is investigating a connection between the drugs and dangerously high acid levels in the blood. They are also looking at whether changes will need to be made to the prescribing information.
“Healthcare professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms,” the FDA said. “Discontinue SGLT2 inhibitors if acidosis is confirmed, and take appropriate measures to correct the acidosis and monitor sugar levels.” The signs and symptoms listed included difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. The FDA is issuing the warning after they searched their database of adverse event complaints. From March 2013 to June 2014 there were 20 cases of DKA reported, most of them with type 2 diabetes as the indication. Hospitalization was required in all of the cases, and the median time to onset was 2 weeks after starting the drug.
“I would encourage that these cases be studied so we can learn the scenarios behind them so they can be broadcast,” said Farhad Zangeneh, MD, medical director of Endocrine, Diabetes and Osteoporosis Clinic, he added that we should look at the background before issuing a general warning against the class. He manages hundreds of patients with the three SGLT2 inhibitors, he said, and has never had any problems. He suggested starting with low doses and making sure that patients are always well hydrated, have no renal problems, and get their lab work done.
Many doctors prescribe SGLT2 inhibitors off-label to type 1 diabetes patients, said Zangeneh, but in that case, the patients should at least be “super-patients” — they should be well controlled, hand-picked, excellent carb-counters.”Certainly this report warrants a closer look at these cases to find out the exact details of the individual scenarios,” he added. Foiqa Chaudhry, MD, an endocrinology fellow at the University of Florida, described two cases of DKA that developed after the patients were taking SGLT2 inhibitors. An 18-year-old female presented with persistent vomiting and abdominal pain for the last 24 hours. She’d had type 2 diabetes since she was 8, but had never had ketoacidosis. She had started taking metformin and canagliflozin 3 weeks earlier, and her primary care physician increased the dosage from 100 mg to 300 mg one week earlier. She was treated for diabetic ketoacidosis with an insulin drip and was eventually discharged.
In the other case, a 55-year-old man presented with dizziness. It was found that he had recently started taking glipizide and dapagliflozin. He was treated for mild DKA and sent home. It is suggested that more specific counseling be given to patients regarding hydration status when being started on this class of medications.”
Potential DKA-triggering factors that were identified in some cases included acute illness or recent significant changes such as infection, urosepsis, trauma, reduced caloric or fluid intake, and reduced insulin dose. Potential factors, other than low insulin levels, contributing to the development of acidosis identified in the cases included low blood volume levels, acute kidney impairment, low blood oxygen levels, reduced oral intake, and a history of alcohol use. But they noted that for half of the cases, there was no triggering factor that was listed.
The FDA asked healthcare professionals to report adverse events and side effects from these products to their MedWatch program.
■ Culled from www.medpagetoday.com.nual to navigate , decode, upgrade and study about what’s right or wrong, the very good, the very bad and treacherous ways of the human mind and its follies.
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