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(Updated August 25, 1999)

Joan Stephenson, PhD

JAMA. 1999;282:515.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

In addition to providing updated recommendations for liver function monitoring, the mailing included a patient information/consent form that noted that the drug "should not be used by patients until there has been . . . [Full Text of this Article]

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