Victoza Pancreatitis Reports Up Since Drug’s Approval
Date Published: Tuesday, June 7th, 2011
A recent report says there is a concern the Type 2 diabetes drug Victoza is linked to serious cases of pancreatitis and related gastrointestinal symptoms, says the U.S. Food and Drug Administration (FDA). In mid-May, the agency released their third quarter data report which details the rising apprehension of Vitoza.
Victoza, the brand name for the liraglutide injection, is a new Type 2 diabetes drug consisting of daily injections of synthetic glucagon-like-peptide-1 (GLP-1). The body chemical GLP-1 is released by the liver in response to food in order to increase the secretion of insulin which limits the elevation of blood sugar following meals, says the FDA.
Victoza is designed to have similar effects to GLP-1; thus, patients (who are typically obese) are likely to lose weight while those treated with other drugs may gain weight.
In January 2010, FDA approval of Victoza was surrounded by controversy due to the agency’s uncertainty about the risk of cardiovascular problems associated with the drug. Additionally, animal studies demonstrated an increased risk of thyroid cancer. According to the agency, the FDA’s unit that reviews animal studies and the clinical safety reviewer were against approving the drug which resulted in a divided vote among the FDA Advisory Committee members.
Two important issues plaguing the committee were: 1) evidence in animal studies showing the risk of thyroid cancer (which was not ruled out in humans) and 2) the lack of additional testing to discount the increased risk of heart attack and stroke.
Nonetheless, the FDA comprised and approved Victoza to include a label warning about thyroid cancer and a “second-line indication” which means “other drugs should be preferred.”
The third quarter 2010 report of Victoza revealed a signal for inflamed pancreas and gastrointestinal symptoms such as nausea, abdominal pain and vomiting. The drug accounted for 70 cases of acute and chronic pancreatitis and 105 cases since the drug’s approval only nine months earlier.
According to the FDA, the Victoza “triggered far more reports of pancreatitis than the oral products with a different mechanism.” The agency also found 13 cases of possible kidney failure or impairment which is an alarming concern since the “FDA safety review cited laboratory test evidence of a possible adverse effect on kidney function.”
There were almost 200,000 dispensed prescriptions for Victoza just nine months after FDA approval. This surge of popularity presented a problem for the agency who hoped the “second-line indication” warning would slow introduction into clinical practice; thus, giving them “an opportunity to gain clinical experience gradually.”
Novo Nordisk, the Danish manufacturer of Victoza, defended the drug saying “epidemiological studies show a higher risk of pancreatitis in diabetes patients, independent of treatment,” says the FDA report.
Date Published: Tuesday, June 7th, 2011
A recent report says there is a concern the Type 2 diabetes drug Victoza is linked to serious cases of pancreatitis and related gastrointestinal symptoms, says the U.S. Food and Drug Administration (FDA). In mid-May, the agency released their third quarter data report which details the rising apprehension of Vitoza.
Victoza, the brand name for the liraglutide injection, is a new Type 2 diabetes drug consisting of daily injections of synthetic glucagon-like-peptide-1 (GLP-1). The body chemical GLP-1 is released by the liver in response to food in order to increase the secretion of insulin which limits the elevation of blood sugar following meals, says the FDA.
Victoza is designed to have similar effects to GLP-1; thus, patients (who are typically obese) are likely to lose weight while those treated with other drugs may gain weight.
In January 2010, FDA approval of Victoza was surrounded by controversy due to the agency’s uncertainty about the risk of cardiovascular problems associated with the drug. Additionally, animal studies demonstrated an increased risk of thyroid cancer. According to the agency, the FDA’s unit that reviews animal studies and the clinical safety reviewer were against approving the drug which resulted in a divided vote among the FDA Advisory Committee members.
Two important issues plaguing the committee were: 1) evidence in animal studies showing the risk of thyroid cancer (which was not ruled out in humans) and 2) the lack of additional testing to discount the increased risk of heart attack and stroke.
Nonetheless, the FDA comprised and approved Victoza to include a label warning about thyroid cancer and a “second-line indication” which means “other drugs should be preferred.”
The third quarter 2010 report of Victoza revealed a signal for inflamed pancreas and gastrointestinal symptoms such as nausea, abdominal pain and vomiting. The drug accounted for 70 cases of acute and chronic pancreatitis and 105 cases since the drug’s approval only nine months earlier.
According to the FDA, the Victoza “triggered far more reports of pancreatitis than the oral products with a different mechanism.” The agency also found 13 cases of possible kidney failure or impairment which is an alarming concern since the “FDA safety review cited laboratory test evidence of a possible adverse effect on kidney function.”
There were almost 200,000 dispensed prescriptions for Victoza just nine months after FDA approval. This surge of popularity presented a problem for the agency who hoped the “second-line indication” warning would slow introduction into clinical practice; thus, giving them “an opportunity to gain clinical experience gradually.”
Novo Nordisk, the Danish manufacturer of Victoza, defended the drug saying “epidemiological studies show a higher risk of pancreatitis in diabetes patients, independent of treatment,” says the FDA report.
