BETHESDA, MD 13 June 2011—A reminder circulated today by FDA`s MedWatch program warns prescribers of liraglutide that the antidiabetic drug may cause acute pancreatitis and deadly thyroid tumors in patients.
According to FDA, these risks mean that the drug is not suitable for first-line therapy in patients with type 2 diabetes mellitus.
Information about the risk of thyroid tumors and pancreatitis has appeared in the drug`s labeling since its approval last year. Also present since then is the recommendation that liraglutide be used as second-line treatment, in conjunction with diet and exercise, for the improvement of glycemic control in adults with type 2 diabetes.
Liraglutide is marketed by Novo Nordisk under the brand name Victoza.
The initial risk evaluation and mitigation strategy (REMS) for liraglutide required Novo Nordisk to establish a cancer registry to identify cases of medullary thyroid cancer in patients who use the drug.
The REMS program was updated last month.
The revised REMS program describes a communication plan that includes multiple letters to health care providers and also requires the company to assess its safety efforts for the drug for the next six years.
A Dear Healthcare Professional letter (PDF) dated June 2011 that is part of the REMS states that liraglutide causes thyroid C-cell tumors in rats and mice and has the potential to do so in humans, although studies have not confirmed this.
The drug is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. Patients who are found during liraglutide therapy to have thyroid nodules should be evaluated by an endocrinologist, according to the letter.
In clinical trials, patients treated with liraglutide were more likely than those given comparator medications to have acute pancreatitis. The letter instructs health care providers to monitor patients for signs and symptoms of pancreatitis when liraglutide therapy is initiated and after a dosage increase.
Liraglutide treatment should be discontinued in patients who are suspected to have pancreatitis, and therapy should not be resumed if the diagnosis is confirmed. Liraglutide should be used with caution in patients with a history of pancreatitis, the letter states.