What does this research mean for the field?

Q: What does this research mean for the field?

The FDA's 1998 regulatory action, which included a boxed warning and a 'Dear Health Care Professional' letter, had no material effect on reducing the contraindicated use of cisapride. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

December 20, 2000

Contraindicated Use of Cisapride

Structured PICO

Does the FDA's 1998 regulatory action reduce the contraindicated use of cisapride in patients prescribed the drug?

Population

Patients with at least 180 days of prior enrollment in 2 managed care organizations or a state Medicaid program who were prescribed cisapride at least once in the 1-year period before (n = 24,840) or after (n = 22,459) regulatory action.

Intervention

FDA's 1998 regulatory action (additions to boxed warning and 'Dear Health Care Professional' letter) regarding contraindicated use of cisapride

Comparator

1-year period before the regulatory action (July 1997-June 1998)

Outcome

Proportion of cisapride users in each period for whom cisapride use was contraindicated by the product labelsafety

The FDA's 1998 regulatory action (boxed warnings and letters) had no material effect on reducing the contraindicated use of cisapride, highlighting the need for more effective drug safety communication.

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 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.

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