WARNING: FDA TO INVESTIGATE VICTOZA-CANCER LINK
Recently, the FDA has moved to evaluate whether or not Victoza (liraglutide), a drug used in GLP-1 therapy for the treatment of type II diabetes is associated with an increased rate for cancer.
Victoza and other GLP-1 therapy drugs have been previously linked to asymptomatic pancreatitis, and it is well-known that pancreatitis is associated with an increased risk for pancreatic cancer, but research showing a specific association between liraglutide and cancer has as yet been inconclusive. This current FDA announcement is regarding a possible connection between Victoza and thyroid cancer.
Though Mayo Clinic states that “Clinical studies have also shown that liraglutide may cause pancreatitis,” some doctors believe the risks associated with Victoza outweigh the risks associated with Victoza use, but this may change if evidence that Victoza causes cancer is documented in peer-reviewed scholarly print.
Here is the original FDA announcement regarding cancer and Victoza:
Victoza (liraglutide [rDNA origin]) Injection: REMS – Risk of Thyroid C-cell Tumors, Acute Pancreatitis
AUDIENCE: Endocrinology, Family Practice
ISSUE: Novo Nordisk reminded healthcare professionals of important safety information about Victoza (liraglutide [rDNA origin]) injection required in a Risk Evaluation and Mitigation Strategy (REMS). The letter is being sent because a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza.
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Additionally, in clinical trials studying Victoza, there were more cases of pancreatitis in patients treated with Victoza than in patients treated with comparators.
BACKGROUND: FDA may require a REMS for newly or already approved prescription drug product when FDA determines that a REMS is necessary to ensure the benefits of a drug outweigh the risks of the drug. Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
RECOMMENDATION: 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 treated with 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, 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).
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[June 2011 – Dear Healthcare Professional Letter – Novo Nordisk]
[May 2011 – Prescribing Information – Novo Nordisk]