he U.S. Food and Drug Administration approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults.
Victoza is intended to help lower blood sugar levels along with diet, exercise, and selected other diabetes medicines. It is not recommended as initial therapy in patients who have not achieved adequate diabetes control on diet and exercise alone.
In five clinical trials involving more than 3,900 people, pancreatitis (inflammation of the pancreas) occurred more often in patients who took Victoza than in patients taking other diabetes medicines. Victoza should be stopped if there is severe abdominal pain, with or without nausea and vomiting, and should not be restarted if pancreatitis is confirmed by blood tests. Victoza should be used with caution in people with a history of pancreatitis.
The most common side effects observed with Victoza were headache, nausea, and diarrhea. Other side effects included allergic-like reactions such as hives.
Victoza was not associated with an increased risk for cardiovascular events in people who were mainly at low risk for these events. FDA approved Victoza, however, with several post-marketing requirements under the Food and Drug Administration Amendments Act (FDAAA) to ensure that the company will conduct studies to provide additional information on the safety of this product.
In addition to a cardiovascular safety study to specifically evaluate the cardiovascular safety of Victoza in a higher risk population, the company also is required to conduct a 5-year epidemiological study using a health claims database to evaluate thyroid and other cancer risks as well as risks for seriously low blood glucose levels (hypoglycemia), pancreatitis, and allergic reactions. To specifically evaluate the risk of medullary thyroid cancer, the company is required to establish a cancer registry to monitor the rate of this type of cancer in the United States over the next 15 years.
In animal studies, Victoza caused tumors of the thyroid gland in rats and mice. Some of these tumors were cancers, which were significantly increased in rats who received excessive doses that were 8-times higher than what humans would receive.
It is not known if Victoza could cause thyroid tumors or a very rare type of thyroid cancer called medullary thyroid cancer in people. For this reason, Victoza should not be used as the first-line treatment for diabetes until additional studies are completed that support expanded use. Also, Victoza should not be used in people 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 known as Multiple Endocrine Neoplasia syndrome type 2.
