Victoza belongs to a class of medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists, which help the pancreas make more insulin after eating a meal.
“Diabetes is a leading cause of death and disability, with more than 1.5 million new cases diagnosed annually,” says Mary Parks, MD, director of the division of metabolism and endocrinology products at the FDA.
“Controlling blood sugar levels is very important to preventing or reducing the long term complications of diabetes, and Victoza offers certain patients with type 2 diabetes a treatment option for controlling their blood glucose levels," Parks says.
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.
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.