FDA ignores own advisors’ advice, eats slice of humble pie
When the U.S. Food and Drug Administration was deciding in 2010 whether to approve the diabetes drug Victoza, two of the agency’s pharmacologists and one of its clinical safety reviewers advised against it, pointing to the Novo Nordisk-manufactured medication’s serious risks.
“In the United States, there are already 11 classes of drugs approved for glycemic control in type 2 diabetes,” the clinical safety reviewer wrote. “The need for new therapies for type 2 diabetes is not so urgent that one must tolerate a significant degree of uncertainty regarding serious risk concerns.”
The FDA went ahead and approved Victoza anyway, but the drug’s detractors were vindicated last summer when post-market reports forced the agency to attach to the medication warnings about pancreatitis, thyroid cancer and renal failure.
Those dangers (along with severe allergic reactions) are cited in a petition filed with the FDA in April asking the agency to pull Victoza from the market.
“More and more people are taking this drug, and more people are experiencing serious health problems as a result,” Dr. Sidney Wolfe, of petition-filing group Public Citizen, said in a statement (Approximately two million prescriptions of Victoza are filled each year). “Clearly, the FDA’s warning system is not sufficient. The drug should be taken off the market.”
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