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December 20, 2000

Drug Labeling Revisions—Guaranteed to Fail?

Author Affiliations

Author Affiliation: Department of Medicine, Georgetown University Medical Center, Washington, DC.

JAMA. 2000;284(23):3047-3049. doi:10.1001/jama.284.23.3047

The article by Smalley et al1 in this issue of THE JOURNAL presents yet another demonstration of the weaknesses in the US system for providing prescription medications to patients. The findings of Smalley et al1 demonstrate the failure of efforts by the manufacturer of cisapride (Propulsid) to communicate to the health care community sufficiently to ensure optimal prescribing and dispensing of this drug. Smalley et al1 reviewed the pharmacy files and demographic records of patients who were prescribed cisapride before and after labeling changes and warning letters were issued by the manufacturer.2 These warnings called attention to new contraindicated uses of cisapride that could result in life-threatening ventricular arrhythmias. This study, a collaboration between 2 academic centers and the Food and Drug Administration (FDA), found that patients with contraindications for the use of cisapride continued to receive the drug at nearly the same rate after the warnings were issued as before they were issued. These observations and the continued receipt of reports of deaths and torsades de pointes by the FDA's voluntary reporting system left the pharmaceutical manufacturer no alternative but to remove the drug from general use and restrict its availability.3