Thursday, January 10, 2013

Public Citizen target canagliflozin

FDA Should Reject Dangerous Diabetes Medication, Public Citizen Tells Advisory Committee

Canagliflozin, Part of a New Class of Diabetes Drugs, Presents Too Many Risks to Patients

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should not approve the diabetes drug canagliflozin because it could significantly harm patients and does not present significant benefit over current medications, Public Citizen said today.

In testimony today before an FDA advisory committee, director of Public Citizen’s Health Research Group Dr. Sidney Wolfe warned that the new drug presents an unsafe increase of risk for low blood pressure symptoms, adverse cardiac events, and genital and urinary infections. He urged the panel to recognize that in no way do these risks outweigh potential benefit over existing diabetes treatments.

Canagliflozin is part of a new class of diabetes drugs called sodium glucose co-transporter-2 inhibitors that work by blocking re-absorption of glucose by the kidney and increasing glucose excretion in the urine to lower blood sugar. This results in a large loss of sugary fluids. Traditional diabetes treatments typically work by improving insulin secretion or insulin sensitivity.

“The fact that the drug works by a uniquely new mechanism to lower blood sugar has not spared of a whole set of unique new risks,” said Wolfe. “The FDA has previously made too many mistakes in approving drugs, including those for diabetes, with no unique clinical benefits and unique risks. The agency shouldn’t approve this one.”

To read today’s testimony, visit:

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