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Popular Diabetes Drugs Receive FDA Warning of Ketoacidosis Risk


FDA Warning for Jardiance Farxiga InvokanaThere are many drugs on the market that help diabetes patients manage their blood sugar levels so that they don’t suffer from life-threatening complications. However, these same drugs have been under scrutiny for causing serious health conditions. In fact, the Food and Drug Administration (FDA) recently added additional warnings to several popular Type 2 diabetes medications.

Invokana, Jardiance and Farxiga, also called sodium-glucose cotransporter-2 (SGLT2) inhibitors, are prescribed to patients who have Type 2 diabetes and are recommended for use in conjunction with a diet and exercise program. They all carry a high risk of ketoacidosis, a serious condition that causes the body to burn fat for energy. When this process occurs, the body produces dangerous chemicals called ketones. Elevated ketone levels can lead to coma or even death. Onset of ketoacidosis can occur within a matter of hours. Initial symptoms include: dry mouth, excessive thirst, frequent urination and high glucose levels. Patients may also experience fatigue, vomiting, abdominal pain and breathing difficulties. The FDA warning notes that high blood glucose levels do not need to be present in order for ketoacidosis to occur. These drugs also carry an increased risk of urinary tract infections (UTIs.) In many cases, UTIs can develop into serious kidney and blood infections requiring hospitalization and even dialysis.

The FDA is requiring that additional warnings be added to all drugs containing the ingredients empagliflozin, canagliflozin or dapagliflozin. The warning comes as a response to the seventy-three adverse event reports that the FDA received, across a two-year time span. The reports indicate a ketoacidosis diagnosis among patients who were using SGLT2 medications. Between March 2013 and October 2014, another nineteen patients reported being hospitalized to treat serious kidney infections and blood infections, believed to be linked to SGLT2 usage. ent FDA warning is a follow-up to its safety review in May 2015, wherein a Drug Safety Communication was released notifying patients and doctors of the ketoacidosis risk.

If you or a loved one have been diagnosied with ketoacidosis while taking Invokana, Invokamet, Jardiance or Farxiga, contact the dangerous drug lawyers of Nadrich & Cohen, LLP for a free consultation. There are strict time limits for making a claim. Call today for a free consultation with one of our dangerous drug specialists.


December 15, 2015

Popular Diabetes Drugs Receive FDA Warning of Ketoacidosis Risk

There are many drugs on the market that help diabetes patients manage their bloo...