After evaluating a safety signal regarding pancreatitis and pancreatic cancer in patients using incretin-based drugs, the Food and Drug Administration and the European Medicines Agency conclude that assertions of a causal association are inconsistent with the data. With approximately 25.8 million diabetic patients in the United States and 33 million in the European Union alone, the growing prevalence of diabetes worldwide poses a major public health challenge. Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are committed to ensuring the safety of drug products marketed for the treatment of diabetes, and postmarketing reports of pancreatitis and pancreatic cancer in patients taking certain antidiabetic medications have been of concern to both agencies. Working in parallel, the agencies have reviewed nonclinical toxicology studies, clinical trial data, and epidemiologic data pertaining to blood glucose-lowering ...
After weighing the risks and benefits, the FDA recently approved two new drugs as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management in obese or overweight adults with at least one weight-related coexisting condition.
On January 25, the FDA approved liraglutide, a glucagon-like-peptide-1 receptor agonist that can improve glycemic control in adults with type 2 diabetes. Drs. Mary Parks and Curtis Rosebraugh discuss the benefits and potentially serious safety concerns associated with this new therapy.
