On March 14, 2013, the FDA issued a Drug Safety Communication, alerting the public to a study that suggested Victoza and other type 2 diabetes medications were linked to an increased risk of pancreatitis and pre-cancerous cellular changes, called pancreatic duct metaplasia. These risks were reportedly found in a group of drugs known as incretin mimetics, which includes Byetta, Bydureon, Victoza, Januvia and other medications.
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At the time, the FDA said it was not changing the safety warnings of the drugs, but that it was reviewing data from the study, including requesting the methodology used so the agency could investigate the risk of pancreatic toxicity.
Other drugs in the incretin mimetic class have been linked to an increased risk of acute pancreatitis, including fatal and nonfatal instances of the condition. When Victoza was approved, the FDA noted that in five clinical trials of Victoza, there were seven cases of pancreatitis in patients using Victoza, compared with one case of pancreatitis in a patient who used a different diabetes medicine.
On April 19, 2012, the public advocacy group Public Citizen filed a petition with the FDA requesting the agency remove Victoza from the market. Public Citizen cited the risk of thyroid cancer, pancreatitis, serious allergic reactions and kidney failure as outweighing any possible benefits to the drug. In a news release, Public Citizen noted that two FDA pharmacologists and an FDA clinical safety reviewer advised against approving Victoza.
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Victoza, known generically as liraglutide, is used to treat type 2 diabetes and is made by Novo Nordisk. It was approved by the FDA in 2010 to treat bype 2 diabetes. When Victoza was approved, the FDA noted that animal data suggested a rare type of thyroid cancer, known as medullary thyroid cancer, was linked to the use of Victoza. According to the FDA, studies in mice and rats showed liraglutide was linked to the development of tumors in the thyroid gland, "especially at doses that were 8-times higher than what humans would receive."
As a result, the FDA requested a Risk Evaluation and Mitigation Strategy for Victoza and further required a five-year epidemiological study of Victoza.
Victoza Cancer Legal HelpIf you or a loved one has suffered damages or injuries from Victoza, please click the link below and your complaint will be sent to a Drug/Medical Device lawyer who may evaluate your claim at no cost or obligation.
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