Ischemic colitis with type I interferons used in the treatment of hepatitis C and multiple sclerosis: An evaluation from the food and drug administration adverse event reporting system and review of the literature [Colitis isquémica con interferonas tipo I usadas en el tratamiento de hepatitis c y esclerosis múltiple: Una evaluación del sistema de reporte de eventos adversos de la administración de drogas y alimentos y revisión de laliteratura]

摘要

Objective: To better characterize the association between type I interferons and ischemic colitis (IC) in patients with the hepatitis C virus (HCV) and multiple sclerosis (MS), by analyzing reports submitted to the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) and the published literature. Data sources: A total of 2,562,390 reports of adverse events between January 2003 and June 2011 were downloaded from the FDA AERS. A literature review was performed on PubMed (January 1966-August 2012) using the MeSH terms interferon or interferon alfa or interferon beta and ischemic colitis separated by the Boolean operator "and" between the first 3 terms and the last term. Additional literature was identified by conducting a hand search of the reference list of the published literature identified in the initial search. Study selection and data extraction: Cases were restricted to those with an indi cation of HCV or MS, a primary suspect drug of a type I interferon, and a reaction of IC. Full-length reports were requested and organized by type of interferon, age, sex, concomitant drugs, and comorbidities. The Naranjo prob a bility scale was used to define cases as definite, probable, possible, or doubtful druginduced adverse events. Data synthesis: Type I interferons, including interferon alfa (IFN-α) and interferon beta (IFN-β), are approved for the treatment of HCV and MS. IFN-α has been shown to induce IC, but a relationship between type I interferons and IC has not been clarified in the medical literature. Fifty-six primary suspect reports of type I interferons associated with IC in patients with HCV or MS were identified from the FDA AERS. Seventeen cases were reported with IFN-α and 39 cases were reported with IFN-β. The majority of the cases were in females (80%) and those between the ages of 50 and 65 years (52%). The Naranjo probability scale identi fied 13 probable and 4 possible cases of IFN-α-induced IC, and 19 probable and 20 possible cases of IFN-β-induced IC. In the literature, 11 cases of IFN-α-induced IC were reported, while there were no reports with IFN-β. Conclusions: Our study suggests a possible association between treatment with type I interferons and the development of IC. Further research to determine the mechanism of this association is warranted.