Product Liability

Doctors warned of risks with type 2 diabetes drug

Pharmaceuticals maker Novo Nordisk is reminding doctors that its type 2 diabetes injectable drug Victoza (liraglutide) can cause serious health problems and is part of a Risk Evaluation and Mitigation Strategy (REMS). REMS are required for newly or already approved prescription drugs in order to ensure the benefits of the drug outweigh the risks associated with it. Victoza is being evaluated to determine if it causes thyroid tumors, thyroid cancers and other serious illnesses.

A recent assessment by Novo Nordisk found that some primary care providers may not be fully aware of the serious risks associated with Victoza.

In studies with laboratory mice and rats, Victoza has been found to cause dose-dependent and treatment-duration-dependent thyroid C-cell tumors. At this time, it is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as those conditions could not be ruled out by clinical or nonclinical studies. Additionally, clinical trials studying the drug identified more cases of pancreatitis in patients treated with Victoza than in patients treated with comparable drugs.

Victoza was approved by the Food and Drug Administration (FDA) in January 2010 as a once-daily injection to treat type 2 diabetes in some adults. The drug was approved with a REMS to determine any risk for acute pancreatitis and medullary thyroid cancer.

As part of the REMS, Novo Nordisk 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.

Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients taking Victoza, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation.

After initiation of Victoza, and after dose increases, doctors should observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting.

Any side effects with this drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/report.htm.