Medical News & Perspectives
August 11, 1999

FDA Weighs Communicating Drug-Related Risk to Patients

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Copyright 1999 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1999American Medical Association

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JAMA. 1999;282(6):515. doi:10.1001/jama.282.6.515-JMN0811-2-1

Obtaining a patient's written informed consent concerning potential risks of a treatment is a measure most people associate with clinical trials or impending surgery, not the prescribing of an approved drug. But in a handful of instances in recent years—most recently within the past couple of months—the US Food and Drug Administration (FDA) and pharmaceutical manufacturers have been advising physicians to obtain consent from patients before prescribing certain drugs.

In June, Abbott Laboratories sent a "Dear Doctor" letter to physicians across the nation, alerting them to an updating of the "Warnings" section in the labeling for pemoline (Cylert), a drug sometimes prescribed for attention-deficit/hyperactivity disorder. The drug carries a small risk of acute liver failure.

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