| Titre : | Contraindicated use of cisapride : Impact of Food and Drug Administration Regulatory Action. (2000) |
| Auteurs : | Falter SMALLEY ; Susan-E ANDRADE ; Karnold CHAN ; Michael GOODMAN ; Jerry GURWITZ ; Richard PLATT ; Wayne-A RAY ; Stephanie-D SCHECH ; Deborah SHATIN ; Diane-K WYSOWSKI ; Center for Health Care Policy and Evaluation. UnitedHealth Group. Minnetonka. MN. USA ; Channing Laboratory. Brigham and women's Hospital. Boston. MA. USA ; Departments of Medicine and Preventive Medicine. Vanderbilt University School of Medicine and Geriatric Research. Education and Clinical Center. And Va Medical Center. Nashville. TN. USA |
| Type de document : | Article |
| Dans : | JAMA - Journal of the american medical association (vol. 284, n° 23, 2000) |
| Pagination : | 3036-3039 |
| Langues: | Anglais |
| Mots-clés : | Thérapeutique médicamenteuse ; Thérapeutique ; Contre indication ; Evaluation ; Recommandation ; Homme |
| Résumé : | [BDSP. Notice produite par INIST 6mDR0x6N. Diffusion soumise à autorisation]. Context Cisapride, a gastrointestinal tract promotility agent, can cause life-threatening cardiac arrhythmias in patients susceptible either because of concurrent use of medications that interfere with cisapride metabolism or prolong the QT interval or because of the presence of other diseases that predispose to such arrhythmias. In June 1998, the US Food and Drug Administration (FDA) determined that use of cisapride was contraindicated in such patients and informed practitioners through additions to the boxed warning in the label and a "Dear Health Care Professional" letter sent by the drug's manufacturer. Objective To evaluate the impact of the FDA's 1998 regulatory action regarding contraindicated use of cisapride. Design and Setting Analysis of data for the 1 - year periods before (July 1997-June 1998) and after (July 1998-June 1999) the regulatory action from the population-based, pharmacoepidemiology research databases of 2 managed care organizations (sites A and B) and a state Medicaid program (site C). Participants Patients with at least 180 days of prior enrollment in 1 of the 3 sites who were prescribed cisapride at least once in the period before (n=24840) or after (n=22459) regulatory action. Patients could be included in both cohorts. Main Outcome Measures Proportion of cisapride users in each period for whom cisapride use was contraindicated by the product label, based on computerized patient medical encounter records. (...) |
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