FDA warns of health risks with diabetes drug
Patients who take the diabetes drug liraglutide may be at increased risk for thyroid cancer and pancreatitis, the FDA warned in a letter to health care professionals.
The agency issued the letter after discovering “some primary care providers are not fully aware of the serious risks associated with the use of liraglutide (Victoza),” they wrote.
Indicated as an adjunct therapy for glycemic control for adults with type 2 diabetes in whom diet and exercise does not provide adequate control, lirglutide is not recommended as a first-line therapy for these patients, according to the agency.
Clinical trial results indicate that liraglutide causes dose-dependent ant treatment-duration-dependent thyroid C-cell tumors in rats and mice. However, the risk for these types of tumors in humans, including medullary throid carcinoma (MTC), has neither been proven nor ruled out in clinical or nonclinical trials.
As a precaution, liraglutide is contraindicated for patients with a personal or family history of MTC and also in patients with multiple endocrine neoplasia syndrome type 2.
“Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation,” the agency wrote.
Although the value of routine serum calcitonin monitoring is unknown, clinicians who detect elevated levels of this hormone in patients taking liraglutide should also refer them to an endocrinologist.
Data from clinical trials also indicate that patients treated with liraglutide experience more cases of pancreatitis than those treated with other drugs for glycemic control.
Clinicians should carefully monitor patients for pancreatitis signs and symptoms —such as severe persistent abdominal pain which sometimes radiates to the back and may or may not be accompanied by vomiting — after initiating treatment with the drug or after dose increases, according to the agency.
Liraglutide should be discontinued among patients with confirmed pancreatitis and should be used with caution among those who have a history of the inflammatory condition.
The FDA encourages health care professionals and patients to report adverse events, side effects or product quality problems to the MedWatch Safety Information and Adverse Event Reporting Program.