FDA Warns of Serious Side Effects from Diabetes Drug Glyxambi

The U.S. Food and Drug Administration (FDA) has issued a warning about adverse effects from taking Glyxambi and other similar type-2 diabetes drugs that can increase the risk of kidney failure and ketoacidosis.

Glyxambi is used by those diagnosed with type-2 diabetes to help control blood sugar levels. Its main ingredient, empagliflozin, assists the kidneys with the removal of glucose from the bloodstream. Another component of the drug — linagliptin — regulates the levels of insulin in the body after eating.

Glyxambi was approved by the FDA in January 2015 and is manufactured by Boehringer Ingelheim and Eli Lilly under the names Jardiance and Tradjenta.

In May 2015, the FDA issued a warning after the agency received multiple reports that a class of type-2 diabetes medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors could lead to diabetic ketoacidosis, a dangerous condition where the body produces high levels of acid in the blood. If left untreated, diabetic ketoacidosis can cause comas and eventually death.

The FDA studied adverse event reports that had been submitted over two years, and found 73 instances where patients taking SGLT2 drugs developed diabetic ketoacidosis. Because these events are always underreported, the FDA decided to have pharmaceutical manufacturers change their warning labels to advise patients and doctors of the risk of developing ketoacidosis and serious urinary or kidney infections.

The medications included in the warning were Glyxambi, Invokana, Invokamet, Jardiance, Farxiga and Xigduo XR. The FDA said that these drugs could cause a range of severe adverse effects, including kidney failure and ketoacidosis, which could lead to hospitalization.

In addition, potential Glyxambi side effects can also include pancreatitis, a severe inflammation of the pancreas that can cause death, kidney failure or disease, and dehydration.

Symptoms of these serious side effects from these type-2 diabetes medications include abdominal pain, difficulty breathing, nausea, vomiting, confusion and high levels of fatigue or depression.

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