The manufacturer of liraglutide has issued a letter to health care professionals reminding them about the increased risk of pancreatitis associated with treatment in patients as well as informing them about the development of thyroid tumors in rodents exposed to clinically relevant doses of liraglutide, the Food and Drug Administration announced on June 13.
The information is not new, but the letter is being sent to clinicians 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," according to the FDA statement. Victoza is the trade name for liraglutide (rDNA origin) injection, which is a glucagonlike peptide-1 (GLP-1) receptor agonist approved by the FDA in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
The letter describes the "potential risk" of thyroid C-cell tumors, including medullary thyroid carcinoma, which may be associated with liraglutide. In both genders of rats and mice, liraglutide causes dose-dependent and treatment duration–dependent thyroid C-cell tumors" at clinically relevant exposures, but the relevance to humans cannot be ruled out by clinical or nonclinical studies, according to the letter. In addition, pancreatitis was more common among patients treated with liraglutide, compared with comparators in clinical trials, so the drug may increase the risk of acute pancreatitis.
Because of these risks, liraglutide is not recommended as first-line therapy, and patients should be observed closely for signs and symptoms of pancreatitis after starting treatment and after dose increases. The company is monitoring cases of medullary thyroid cancer registry cases to determine whether there was an increase in cases associated with the availability of liraglutide in the United States.
More information including a link to the letter is available in the FDA statement. Serious adverse events associated with liraglutide should be reported online at MedWatch or by phone at 800-332-1088 or to Novo Nordisk at 877-484-2869.