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June 5, 2014

Dangerous Diabetes Drug Liraglutide Likely Causes Acute Pancreatitis, According to New Public Citizen Study

Study Confirms Earlier Findings, Follows FDA Denial of Public Citizen Petition to Ban Drug

WASHINGTON, D.C. – A new Public Citizen study referenced in a letter sent today to the U.S. Food and Drug Administration (FDA), and posted online, reinforces the case that the diabetes drug liraglutide can cause pancreatitis and should be banned immediately by the FDA.

Liraglutide, whose brand name is Victoza, is one of several drugs in a class known as incretin mimetics approved to treat Type 2 diabetes (the others are exenatide [Byetta], albiglutide [Tanzeum], sitagliptin [Januvia], saxagliptin [Onglyza], linagliptin [Tradjenta] and alogliptin [Nesina]). In April 2012, Public Citizen petitioned the FDA to ban liraglutide because its risks, which include thyroid cancer, in addition to pancreatic toxicity, far outweigh its marginal benefits.

The number of prescriptions filled for liraglutide is on the rise, from 1.5 million prescriptions filled in 2011 to 2.6 million in 2013. Despite the medication’s dangers, an FDA advisory committee on Sept. 11 will consider approving liraglutide to treat obesity.

Today’s study follows the FDA’s recent denial of Public Citizen’s petition. In its letter, the FDA failed to note numerous studies that have been published since the 2012 petition that confirm the risk of liraglutide-associated acute pancreatitis.

In the letter sent today to the agency responding to the denial, Public Citizen cited four such studies, including one randomized controlled weight loss trial in non-diabetic obese and overweight subjects that showed that high-dose liraglutide tripled the risk of acute pancreatitis.

The letter also mentioned a study of the French national drug surveillance database that demonstrated that pancreatitis adverse events seem unique to the incretin mimetic class of diabetes drugs, with much lower numbers of cases occurring in diabetics taking other drugs for their disease.

Public Citizen’s study analyzed adverse event reports submitted to the FDA’s Adverse Event Reporting System (AERS) by health care providers and patients. Previous studies analyzing AERS data on pancreatitis (with liraglutide and other incretin mimetics) examined only the electronic summaries, not the detailed reports themselves, making it much more difficult to discern whether other drugs or causes were involved.

Public Citizen’s analysis revealed 278 cases of acute pancreatitis in patients using liraglutide during the first two years after it was approved, in which liraglutide was considered by the reporter to be the primary suspect in causing the adverse event. Sixty percent (164) of the cases required hospitalization, and two patients died from complications of acute pancreatitis.

Applying the widely used Naranjo causality criteria, liraglutide was classified as the “probable” cause of 51 cases, including 12 for which a causal link was deemed highly probable. Liraglutide was considered the “definite” cause of one case, in which the patient’s pancreatitis that had occurred while taking liraglutide improved after the drug was stopped, but recurred when liraglutide was restarted, and, finally, resolved again when liraglutide was discontinued a second time. This pattern, known as a positive rechallenge, is considered one of the strongest indicators of a causal link between a drug and an adverse event, and this case represents the first such documented report with liraglutide.

“Because of low reporting rates to the FDA’s database, the 278 cases we found likely represent a small fraction of patients who have developed acute pancreatitis while using liraglutide,” said Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group and a co-author of the study.

The new results confirm those seen in the pre-marketing randomized clinical trials of liraglutide that showed that pancreatitis (both acute and chronic) was almost four times more likely to occur in patients taking liraglutide than in those taking a placebo.

Despite this and other risks evident at the time of approval, liraglutide was ultimately approved by the FDA in 2010, against the advice of the agency’s two reviewing pharmacologists and Dr. Karen Mahoney, the FDA’s clinical safety reviewer of the application. In her statement against the approval, Dr. Mahoney said, “The clinical safety reviewer does not recommend approval of liraglutide at this time … In the United States, there are already 11 classes of drugs approved for glycemic control in type 2 diabetes … 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.”

“It was clear at the time of approval – and remains the case – that liraglutide’s risks far outweigh its marginal benefits in diabetic patients,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, and a co-author of the study. “Since liraglutide was first approved, we have warned readers of ‘Worst Pills, Best Pills News’ and WorstPills.org that we consider it to be a “do not use” medication, a category in which we have also placed all of the other incretin mimetic drugs [see list above]. The potential expansion of liraglutide to include treatment of obesity, at a dose 1.7 times higher than that for diabetes, is extremely worrying.”

Read Public Citizen’s study and letter to the FDA  here.

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