Author Affiliation: Department of Medicine, Georgetown University Medical Center, Washington, DC.
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
Woosley RL. Drug Labeling Revisions—Guaranteed to Fail?. JAMA. 2000;284(23):3047–3049. doi:10.1001/jama.284.23.3047
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