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FDA Investigating Type 2 Diabetes Drugs

The U.S. Food and Drug Administration (FDA) is investigating diabetes drugs used to treat Type 2 diabetes made by Johnson & Johnson, AstraZeneca PLC and Eli Lilly and Company after 20 cases of ketoacidosis that required hospitalization were reported, according to BioSpace.com.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors used to treat type 2 diabetes may lead to severe diabetic ketoacidosis, warns the FDA. The alert has implications for Invokana, manufactured by Johnson & Johnson; dapagliflozin, also known as Farxiga, and combination drug Xigduo XR, dapagliflozin/metformin, both developed by AstraZeneca; empagliflozin, or Jardiance, and Glyxambi, both made by Eli Lilly and Germany-based Boehringer Ingelheim.

A search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014. Each of the patients required hospitalization or emergency room treatments. The FDA said it has received additional reports of patients requiring hospitalization since June of 2014, but it did not specify how many.

Ketoacidosis, is a serious condition where the body produces high levels of blood acids called ketones, according to the FDA. SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar levels in adults with type 2 diabetes, the BioSpace.com article notes. Diabetic ketoacidosis most commonly occurs in patients with type 1 diabetes and is usually accompanied by high blood sugar levels, the FDA said.

Although it encouraged people prescribed these medications to continue taking them as directed by doctors, the FDA warned that patients taking these SGLT2 inhibitors should monitor themselves for any signs of ketoacidosis and “seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion and unusual fatigue or sleepiness.”

If the FDA investigation results in new warning labels, it could mean a financial loss for the companies.

Source: BioSpace.com