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Toxic Diabetes Medication Should Not Be Approved for Weight Loss, Public Citizen Tells FDA Advisory Committee

Sept. 11, 2014         

Toxic Diabetes Medication Should Not Be Approved for Weight Loss, Public Citizen Tells FDA Advisory Committee

Proposed Dose 67 Percent Higher Than That Approved for Diabetic Patients

WASHINGTON, D.C. – Liraglutide is too toxic to be approved for weight loss at a dose higher than that approved for diabetes and in patients that will receive little, if any, long-term benefit, Public Citizen told the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee in testimony today.

More than two-thirds of all Americans are overweight and one-third are obese. Numerous medications have been approved in the past as “quick fixes” for this extremely complex, pervasive and often lifelong condition, yet almost all have since been pulled from the market after causing fatal heart attacks and other cardiovascular side effects. In its testimony, Public Citizen also pointed out that no diet drug has ever been shown to prolong survival or improve patients’ long-term health.

Liraglutide, which is administered by injection, is marketed by Novo Nordisk under the brand-name Victoza for the treatment of type 2 diabetes at a dose that has been associated with a litany of serious side effects, including thyroid cancer, pancreatitis and kidney failure. Because of these risks, Public Citizen petitioned the FDA in 2012 to ban liraglutide, but the petition was recently denied by the agency.

In the pre-marketing studies testing liraglutide at a higher dose (proposed brand-name Saxenda) for weight loss, subjects on liraglutide lost an average of approximately 5 percent of their previous weight compared with those given a placebo. Yet, as was the case with Victoza, subjects given Saxenda experienced higher rates of nausea, vomiting, pancreatitis and thyroid cancer compared to those given a placebo. In addition, Saxenda caused an increase in heart rate that has, in the cases of several now-banned weight loss drugs, been shown to predict future adverse cardiovascular effects.

“Liraglutide is too dangerous to use at the current dose in diabetic patients,” said Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group. “Exposing relatively younger, healthier overweight and obese patients to an even higher dose, in some cases for life, is dangerously misguided and will provide little more than false hope to the millions of Americans struggling with their weight.”

Read Public Citizen’s testimony.