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FDA Petitioned to Ban Victoza for Pancreatitis Risks

FDA Petitioned to Ban Victoza for Pancreatitis Risks

June 6, 2014 — The FDA has received yet another petition to ban Victoza (liraglutide) from the consumer-advocacy group Public Citizen. The group is concerned about the increased risk of pancreatitis (pancreatic inflammation) compared to other diabetes medications.

Public Citizen originally petitioned the FDA to ban Victoza in 2012. After a lengthy review, the FDA declined to ban the drug in March of this year. Public Citizen responded with a letter published on June 5 citing four additional studies linking Victoza and pancreatitis.

According to the letter:

“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.”

One study cited by Public Citizen found a tripled increased risk of pancreatitis among non-diabetic obese and overweight subjects who were taking Victoza for weight-loss. Another study evaluated MedWatch adverse event reports during the first two years Victoza was on the market — February 2010 through December 2011. During this time, Victoza was linked to 278 cases of acute pancreatitis. Victoza was a “probable” cause in 51 reports and “highly probable” in 12 reports.

The FDA already requires warnings about the risk of acute pancreatitis on the label for drugs in the incretin mimetic class. In 2011, they warned that Victoza was associated with more cases of acute pancreatitis than other diabetes drugs in clinical trials.

Warnings were added to the label on Byetta (exenatide) in 2007 and Januvia (sitagliptin) in 2009. In 2013, the FDA began investigating a study linking these drugs to cases of pre-cancerous pancreatic growths. Experts are concerned because chronic pancreatitis is a risk-factor for pancreatic cancer.

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The Schmidt Firm, PLLC is currently accepting Victoza induced injury cases in all 50 states. If you or somebody you know has been injured by pancreatitis or pancreatic cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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