0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Commentary |

Drug Labeling Revisions—Guaranteed to Fail?

Raymond L. Woosley, MD, PhD
JAMA. 2000;284(23):3047-3049. doi:10.1001/jama.284.23.3047.
Text Size: A A A
Published online

Extract

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

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

First Page Preview

View Large
First page PDF preview

Figures

Tables

References

Letters

CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Web of Science® Times Cited: 26

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

Related Content

Customize your page view by dragging & repositioning the boxes below.

See Also...
Articles Related By Topic
Related Collections
PubMed Articles
Conjugated Polymer Nanoparticles for Cell Membrane Imaging. Chem Asian J Published online Sep 8, 2014.;
Primary Care Physicians' Use of FDA-Approved Prescription Drug Labels. J Am Board Fam Med 2014 Sep-Oct;27(5):694-8.
Jobs
brightcove.createExperiences();