FDA's Victoza Decision
The FDA approved Victoza based on five clinical trials involving more than 3,900 people. In those trials, pancreatitis (inflammation of the pancreas) occurred more often in patients who took Victoza than in patients taking other diabetes medicines.
The FDA states that Victoza should be stopped if patients experience severe abdominal pain, with or without nausea and vomiting, and should not be restarted if blood tests confirm that they have pancreatitis. Victoza should be used with caution in people with a history of pancreatitis, according to the FDA.
The most common side effects observed with Victoza in the clinical trials were headache, nausea, and diarrhea. Other side effects included allergic-like reactions such as hives.
In its clinical trials, Victoza was not linked to an increased risk of cardiovascular events -- including heart attack, stroke, and death caused by heart disease -- in people who were mainly at low risk for such events. In keeping with FDA policy, Victoza will be studied further to check its cardiovascular safety in higher-risk groups.
Other postmarketing studies will evaluate the risk of thyroid cancer and other cancer risks, as well as the risks of seriously low blood glucose levels ( hypoglycemia), pancreatitis, and allergic reactions.
The FDA notes that in animal studies, Victoza caused tumors of the thyroid gland in rats and mice. Some of those tumors were cancers, which were more likely in rats that got doses of Victoza that were eight times higher than what people would receive.
It's not known if Victoza could cause thyroid tumors or a very rare type of thyroid cancer called medullary thyroid cancer in people. For that reason, the FDA says Victoza should not be used as the first treatment for diabetes until more studies are done.
Victoza should not be used in people who are already at risk for medullary thyroid cancer, such as those who have medullary thyroid cancer in the family, or those with a rare genetic condition called multiple endocrine neoplasia syndrome type 2.
Victoza has a risk evaluation and mitigation strategy to help patients and health-care providers understand the drug's risks and to ensure that the drug's benefits outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid cancer.
Victoza is made by the drug company Novo Nordisk. The launch price of the 1.2-milligram dose will be $8.03 a day.