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Drug Labeling RevisionsGuaranteed to Fail?
Raymond L. Woosley, MD, PhD
JAMA. 2000;284:3047-3049.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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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 . . . [Full Text of this Article]
Author Affiliation: Department of Medicine, Georgetown University Medical Center, Washington, DC.
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