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 Endocrinologic and Metabolic Drugs Advisory Committee Thursday.
More than two-thirds of all Americans are overweight and one-third are obese.
Many medications have been approved in the past as “quick fixes” for these conditions, but almost all have been pulled from the market after causing fatal heart attacks and other cardiovascular side effects, Public Citizen said.
In its testimony, the group also said that no diet drug has been shown to prolong survival or improve patients’ long-term health.
Liraglutide, an injection marketed by Novo Nordisk as Victoza, is used to treat type 2 diabetes at a dose associated with serious side effects, including thyroid cancer, pancreatitis, and kidney failure, Public Citizen said. Because of these risks, it petitioned the FDA in 2012 to ban liraglutide, but the petition was recently denied by the agency.
In studies of liraglutide at a higher dose – with the proposed brand name of Saxenda – for weight loss, people on liraglutide lost an average of about 5 percent of their previous weight compared with those given a placebo.
However, people taking Saxenda, just like those given Victoza, had higher rates of nausea, vomiting, pancreatitis, and thyroid cancer compared to those given a placebo, Public Citizen said. In addition, Saxenda increased heart rate, a predictor of future harmful cardiovascular effects in several banned weight loss drugs.
“Liraglutide is too dangerous to use at the current dose in diabetic patients,” said Sammy Almashat, M.D., 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,” Almashat said.
