Controversies were already surrounding Victoza (liraglutide) even before it was approved by the U.S. Food and Drug Administration (FDA) in 2010. Reports have it that upon approving Victoza, the FDA disregarded the recommendations of three of its drug safety officers. These are two FDA pharmacologists and an FDA clinical safety reviewer who were against the approval of Victoza. At that time, the FDA’s clinical safety reviewer pointed out that there were already 11 other drugs approved for type 2 diabetes. Thus, there was a less necessity to approve a new drug with uncertain safety features, the reviewer further explains.
Victoza, known generically as liraglutide, is used to treat type 2 diabetes manufactured by Novo Nordisk. Media reports say it that the sales for Victoza have quickly increased ever since it was out on the market. In the first full year, Victoza prescriptions generated more than $1 billion in sales. Furthermore, in 2012, a total of $1.6 billion in sales was generated by the drug.
However, Victoza has been a constant subject for scrutiny by U.S. regulators for its potential link to renal impairment, pancreatitis, pancreatic cancer, thyroid cancer and other adverse side effects.
In May 2011, a warning was added to the “Warning and Precautions” section of the Victoza label pertaining to the drug’s linkage to renal impairment. The additional label advises doctors to “use caution when initiating or escalating doses of Victoza in patients with renal impairment.”
Liraglutide, Victoza’s active ingredient, causes “dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice,” according to an FDA warning released on June 13, 2011. Furthermore, the FDA’s Adverse Event Reporting System had documented 25 claims of Victoza thyroid cancer from February 2010 to September 2011.
According to the same June 2011 FDA alert, there were also no less than 200 cases of acute pancreatitis and 28 cases of pancreatic cancer reported during the same period of time.
In March 2013, the FDA reported that they conducted a study about the possible risk of pancreatic cancer with Victoza and other incretin mimetics use. The result of the study says that after pancreas tissue of former users of the drugs suggested inflammation of the pancreas and pre-cancer cell changes called pancreatic duct metaplasia.
Despite all the adverse complaints regarding Victoza use, no Victoza lawsuits have been filed against its manufacturer. Various legal experts have expressed that they may assist the affected patients for possible Victoza settlements. Other drugs in the same medication class have already been recent subject of lawsuits.
References:
diabetesmine.com/2011/06/newsflash-fda-issues-warning-on-victoza.html
netdoctor.co.uk/diabetes/medicines/victoza.html
fda.gov/downloads/Drugs/DrugSafety/UCM199170.pdf
Victoza, known generically as liraglutide, is used to treat type 2 diabetes manufactured by Novo Nordisk. Media reports say it that the sales for Victoza have quickly increased ever since it was out on the market. In the first full year, Victoza prescriptions generated more than $1 billion in sales. Furthermore, in 2012, a total of $1.6 billion in sales was generated by the drug.
However, Victoza has been a constant subject for scrutiny by U.S. regulators for its potential link to renal impairment, pancreatitis, pancreatic cancer, thyroid cancer and other adverse side effects.
In May 2011, a warning was added to the “Warning and Precautions” section of the Victoza label pertaining to the drug’s linkage to renal impairment. The additional label advises doctors to “use caution when initiating or escalating doses of Victoza in patients with renal impairment.”
Liraglutide, Victoza’s active ingredient, causes “dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice,” according to an FDA warning released on June 13, 2011. Furthermore, the FDA’s Adverse Event Reporting System had documented 25 claims of Victoza thyroid cancer from February 2010 to September 2011.
According to the same June 2011 FDA alert, there were also no less than 200 cases of acute pancreatitis and 28 cases of pancreatic cancer reported during the same period of time.
In March 2013, the FDA reported that they conducted a study about the possible risk of pancreatic cancer with Victoza and other incretin mimetics use. The result of the study says that after pancreas tissue of former users of the drugs suggested inflammation of the pancreas and pre-cancer cell changes called pancreatic duct metaplasia.
Despite all the adverse complaints regarding Victoza use, no Victoza lawsuits have been filed against its manufacturer. Various legal experts have expressed that they may assist the affected patients for possible Victoza settlements. Other drugs in the same medication class have already been recent subject of lawsuits.
References:
diabetesmine.com/2011/06/newsflash-fda-issues-warning-on-victoza.html
netdoctor.co.uk/diabetes/medicines/victoza.html
fda.gov/downloads/Drugs/DrugSafety/UCM199170.pdf
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