Pancreatic Safety of Incretin-Based Drugs — FDA and EMA Assessment
| Autor: | Amy Egan, Kristina Dunder, Curtis Rosebraugh, B. Timothy Hummer, Pieter A. de Graeff, Todd Bourcier, Eberhard Blind |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
medicine.medical_specialty
Drug Evaluation Preclinical Incretin Pharmacology Incretins Food and drug administration Mice Pancreatic cancer medicine Drug approval Animals Humans Hypoglycemic Agents media_common.cataloged_instance In patient European Union European union Intensive care medicine Drug Approval media_common United States Food and Drug Administration business.industry digestive oral and skin physiology General Medicine medicine.disease United States Rats Pancreatic Neoplasms Diabetes Mellitus Type 2 Pancreatitis Causal association business |
| Zdroj: | New England Journal of Medicine, 370(9), 794-797. MASSACHUSETTS MEDICAL SOC |
| ISSN: | 1533-4406 0028-4793 |
| Popis: | 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 ... |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|