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Impact of Food and Drug Administration Regulatory Action

Walter Smalley, MD, MPH; Deborah Shatin, PhD; Diane K. Wysowski, PhD; Jerry Gurwitz, MD; Susan E. Andrade, DSc; Michael Goodman, PhD; K. Arnold Chan, MD, DSc; Richard Platt, MD, MS; Stephanie D. Schech, MPH; Wayne A. Ray, PhD

JAMA. 2000;284:3036-3039.

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 = 24 840) or after (n = 22 459) 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 approximately 2 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 no material effect on contraindicated cisapride use. More effective ways to communicate new information about drug safety are needed.

Author Affiliations: Departments of Medicine and Preventive Medicine, Vanderbilt University School of Medicine and Geriatric Research, Education and Clinical Center, and VA Medical Center, Nashville, Tenn (Drs Smalley and Ray); Center for Health Care Policy and Evaluation, UnitedHealth Group, Minnetonka, Minn (Dr Shatin and Ms Schech); Office of Postmarketing Drug Risk Assessment, Food and Drug Administration, Rockville, Md (Dr Wysowski); Fallon Healthcare System and Meyers Primary Care Institute, University of Massachusetts Medical School, Worcester (Dr Gurwitz); College of Pharmacy, University of Rhode Island, Kingston (Dr Andrade); HealthPartners Research Foundation, Bloomington, Minn (Dr Goodman); Channing Laboratory, Brigham and Women's Hospital (Drs Chan and Platt), Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care (Dr Platt), and Harvard Medical School, (Drs Chan and Platt) Boston, Mass.

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