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FDA Requires More Warnings for Diabetes Drug

FDA Requires More Warnings for Diabetes Drug

According to the Centers for Disease Control and Prevention (CDC), 29 million Americans have diabetes. This is nearly 10 percent of the entire population. Another 86 million have a condition called “prediabetes,” which means their blood sugar levels are elevated but not high enough to be classified as type 2 diabetes.

With so many people suffering from the disease, drug manufacturers make numerous medications to treat and manage diabetes. Because diabetes has no known cure, diabetes drugs are massive revenue generators for pharmaceutical companies.

FDA Announces New Warnings, Tests For SGLT2 Inhibitors

The American Diabetes Association reports that the economic burden associated with diabetes was more than $322 billion in 2012 alone. To relieve the high cost of managing diabetes, many sufferers turn to new, innovative medications to keep their blood sugar levels in check. SGLT2 Inhibitors have been described as “the latest thing” in diabetes management.

Approved in 2013, SGLT2 Inhibitors come in pill form and help diabetes patients by preventing the kidneys from reabsorbing a certain protein. Instead, the protein is flushed out of the body through the urine. The drugs go by a number of name brands, including Invokana, Farxiga, and Jardiance.

On December 4, 2015, however, the Food and Drug Administration (FDA) announced it is requiring drug manufacturers to add new warnings to the labels of all SGLT2 Inhibitors warning consumers of a heightened risk of severe urinary tract infections and ketoacidosis, which is a serious condition that causes too much acid to accumulate in an individual’s blood. Patients suffering from ketoacidosis can experience nausea, vomiting, fatigue, difficulty breathing, and abdominal pains. Left untreated, both urinary tract infections and ketoacidosis can lead to death.

The FDA based its warning on results of a review of its Adverse Event Reporting System database. Between March 2013 and May 2015, there were 73 reported cases of ketoacidosis in diabetes patients taking an SGLT2 Inhibitor. During the same time period, there were 17 identified cases of urosepsis (blood infections) and pyelonephritis (kidney infections) brought about by a urinary tract infection caused by an SGLT2 Inhibitor.
Besides the new warning labels, the FDA is also requiring drug makers to conduct additional studies of SGLT2 Inhibitors.