June 6, 2014 — The consumer advocacy group Public Citizen is again calling for the FDA to ban Victoza (liraglutide), a type-2 diabetes treatment manufactured by Novo Nordisk, because it can cause pancreatitis.
“Given the range of known safer, alternative pharmacologic and nondrug treatments for diabetes, this decision to allow continued sales of liraglutide will unnecessarily continue to expose hundreds of thousands of patients to the drug’s serious risks.”
In 2012, Public Citizen petitioned the FDA to ban Victoza. The petition was denied in March. Public Citizen decided to respond by submitting another petition to ban Victoza, citing four new studies that support a link between Victoza and pancreatitis. One study of non-diabetic obese and overweight subjects found that high-dose Victoza tripled the risk of pancreatitis.
Public Citizen also cited an analysis of MedWatch adverse event reports submitted to the FDA from February 1, 2010 through December 31, 2011, roughly the first two years after Victoza was approved. There were 278 case reports of acute pancreatitis associated with Victoza, including 51 cases where Victoza was the “probable” causative agent and 12 cases for which a causal link was “highly probable.”
The FDA issued safety communications about the risk of acute pancreatitis associated with other drugs in the incretin mimetic class, including Byetta (exenatide) in 2007 and Januvia (sitagliptin) in 2009. All drugs in the incretin mimetic class, including Victoza, now carry warnings about acute pancreatitis on the label. In 2011, the FDA warned that clinical trials of Victoza found more cases of pancreatitis than other diabetes drugs.
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