As part of the approval for liraglutide (Saxenda—Novo Nordisk), FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) to inform patients and health care providers about the potential risks associated with the drug.
Liraglutide, which belongs to the class of medications called glucagon-like peptide-1 receptor agonists, received FDA approval on December 23, 2014, as an adjunct to a reduced calorie diet and increased physical activity for weight loss in adults, according to Novo Nordisk. The drug is approved for patients who are considered obese (BMI of 30 kg/m2 or greater) or are overweight (BMI 27 kg/m2 or greater) with at least one weight-related comorbid condition, such as hypertension or type 2 diabetes.
Potential risks associated with liraglutide include medullary thyroid carcinoma and the risk of acute pancreatitis, including necrotizing pancreatitis. The risk of pancreatitis appears to be small, according to Stuart T. Haines, PharmD, Professor and Vice Chair for Clinical Services at the University of Maryland School of Pharmacy. But patients should be warned—as the Medication Guide spells out—about the symptoms. Medullary thyroid cancers have only been seen in animal models, with the risk to humans is still unknown, said Haines.
The safety of liraglutide is also not well known in this indication at a higher dose, according to Haines.
“Liraglutide has been used in lower doses for the treatment of type 2 diabetes by hundreds of thousands of patients,” said Haines. “But we don't have nearly as much experience using it in the higher doses that are approved for weight loss yet.”
He speculates that this may be one reason for the REMS.
Liraglutide has been used for the past 5 years for the treatment of type 2 diabetes. While a REMS could have certainly been included for the drug’s diabetes indication, there’s a large difference in what’s an acceptable risk for treating weight loss versus a disease like diabetes that already has inherent risks, according to Haines.
“If they are using this for weight loss, there are some potential long-term consequences people should be warned about,” said Haines.
He sees weight loss—and the prevention of complications of obesity including diabetes—as a natural extension of this class of drugs.