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Titolo:
Contraindicated use of cisapride - Impact of food and drug administration regulatory action
Autore:
Smalley, W; Shatin, D; Wysowski, DK; Gurwitz, J; Andrade, SE; Goodman, M; Chan, KA; Platt, R; Schech, SD; Ray, WA;
Indirizzi:
Vanderbilt Univ, Med Ctr, Sch Med, Dept Prevent Med, Nashville, TN 37232 USA Vanderbilt Univ Nashville TN USA 37232 event Med, Nashville, TN 37232 USA Vanderbilt Univ, Sch Med, Dept Med, Nashville, TN 37212 USA Vanderbilt Univ Nashville TN USA 37212 Dept Med, Nashville, TN 37212 USA VA Med Ctr, Ctr Geriatr Res Educ & Clin, Nashville, TN USA VA Med Ctr Nashville TN USA r Geriatr Res Educ & Clin, Nashville, TN USA Unitedhlth Grp, Ctr Hlth Care Policy & Evaluat, Minnetonka, MN USA Unitedhlth Grp Minnetonka MN USA re Policy & Evaluat, Minnetonka, MN USA US FDA, Off Postmkt Drug Risk Assessment, Rockville, MD 20857 USA US FDA Rockville MD USA 20857 ug Risk Assessment, Rockville, MD 20857 USA Univ Massachusetts, Sch Med, Fallon Healthcare Syst, Worcester, MA USA Univ Massachusetts Worcester MA USA n Healthcare Syst, Worcester, MA USA Univ Massachusetts, Sch Med, Meyers Primary Care Inst, Worcester, MA USA Univ Massachusetts Worcester MA USA Primary Care Inst, Worcester, MA USA Univ Rhode Isl, Coll Pharm, Kingston, RI 02881 USA Univ Rhode Isl Kingston RI USA 02881 , Coll Pharm, Kingston, RI 02881 USA Healthpartners Res Fdn, Bloomington, MN USA Healthpartners Res Fdn Bloomington MN USA s Res Fdn, Bloomington, MN USA Harvard Pilgrim Hlth Care, Dept Ambulatory Care & Prevent, Boston, MA USA Harvard Pilgrim Hlth Care Boston MA USA y Care & Prevent, Boston, MA USA Brigham & Womens Hosp, Channing Lab, Boston, MA 02115 USA Brigham & WomensHosp Boston MA USA 02115 nning Lab, Boston, MA 02115 USA Harvard Univ, Sch Med, Boston, MA USA Harvard Univ Boston MA USAHarvard Univ, Sch Med, Boston, MA USA
Titolo Testata:
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
fascicolo: 23, volume: 284, anno: 2000,
pagine: 3036 - 3039
SICI:
0098-7484(200012)284:23<3036:CUOC-I>2.0.ZU;2-X
Fonte:
ISI
Lingua:
ENG
Soggetto:
TORSADES-DE-POINTES; CLARITHROMYCIN;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
12
Recensione:
Indirizzi per estratti:
Indirizzo: Ray, WA Vanderbilt Univ, Med Ctr, Sch Med, Dept Prevent Med, Med Ctr N,A-1124, Nashville, TN 37232 USA Vanderbilt Univ Med Ctr N,A-1124 Nashville TN USA 37232 37232 USA
Citazione:
W. Smalley et al., "Contraindicated use of cisapride - Impact of food and drug administration regulatory action", J AM MED A, 284(23), 2000, pp. 3036-3039

Abstract

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 thatpredispose 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. Results In the year prior to regulatory action, cisapride use was contraindicated for 26%, 30%, and 60% of users in study sites A, B, and C, respectively. In the year after regulatory action, use was contraindicated for 24%,28%, and 58% of users, a reduction in contraindicated use of approximately2 per 100 cisapride users at each site. When the analysis was restricted to new users of cisapride after regulatory action, only minor reductions in contraindicated use were found. Conclusion The FDA's 1998 regulatory action regarding cisapride use had nomaterial effect on contraindicated cisapride use. More effective ways to communicate new information about drug safety are needed.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 29/03/20 alle ore 15:03:31