Healthy Skepticism Library item: 7803

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Kesselheim AS, Avorn J.
The Role of Litigation in Defining Drug Risks
JAMA 2007 Jan 17; 297:(3):308-311
http://jama.ama-assn.org/cgi/content/full/297/3/308

Abstract:

In the past decade, several widely used prescription medications have been observed to cause life-threatening adverse effects, and some have been removed from the market. When an approved medication is found to be unsafe, the courts are sometimes called on to determine fault and allocate remedies for injured parties. But in modern prescription drug cases, litigation has taken on additional significance. There are often important gaps in the ascertainment and reporting of adverse effects associated with prescription drugs, and the balance of information presented to physicians about the risks and benefits of medications may understate the former and inflate the latter.1 However, once it approves a drug, the US Food and Drug Administration (FDA) has limited authority to mandate further collection of data to better define adverse effects or to ensure compliance with suggested alterations in marketing practices.2 In this . . .

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