Product News and Recalls

FDA Issues Warning for Type-II Diabetes Medications

sglt2 inhibitors get FDA warningYet another warning regarding dangerous side effects associated with approved medications has been issued by the FDA.

Three specific drugs developed for the treatment of Type-II diabetes have been singled out for their capacity to cause a dangerous blood condition.

Patients taking canagliflozin, dapagliflozin, and empagliflozin should contact their doctors to discuss the possibility of ketoacidosis – a condition where the patient’s body starts producing an overabundance of blood acids. This condition can lead to hospitalization, coma, or death and should be taken seriously.

The three medications are a part of a class of drug known as sodium-glucose cotransporter-2, or SGLT2 inhibitors. They were approved as a way to treat Type-II diabetes when used in conjunction with exercise and changes in diet. Under optimal circumstances, they can help to lower blood sugar levels in adults suffering from the condition. They are marketed under a variety of names including Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance, and Glyxambi.

Type-II diabetes can be devastating when left untreated. Kidney damage and heart disease have been reported as well as nerve damage. Some Type-II diabetes patients also suffer from blindness.

If current trends continue, the Centers for Disease Control and Prevention (CDC) are predicting a dramatic increase in the number of Americans to be diagnosed with Type-II diabetes. Both a treatable and preventable condition, this increase is largely seen as a reflection on the American population’s tendency toward processed foods high in sugar and a largely sedentary lifestyle. These factors, according to the CDC, will lead to a 40% jump in the number of new diabetes diagnoses in the country.

20 cases of ketoacidosis in patients being treated with SGLT2 inhibitors were reported from March 2013 through the first week of June 2014. Every patient being treated for the ketoacidosis required either an emergency room visit or complete hospitalization.

Patients and health care professionals that are aware of dangerous side effects as a result of taking an SGLT2 inhibitor are asked to contact the FDA’s MedWatch program.