BMJ  2006;332:488 (25 February), doi:10.1136/bmj.332.7539.488-a

Letter

Case reports of suspected adverse drug reactions

Case reports generate signals efficiently

The first 150 words of the full text of this article appear below.

EDITOR—Loke et al judge the value of case reports of suspected adverse drug reactions by the outcome measures of further formal validation and the incorporation into the product information.1 They conclude that such reports are of limited value.

The main sources of information or tools that are available for detecting and evaluating suspected adverse drug reactions are spontaneous reports, formal epidemiological studies and controlled clinical trials, and meta-analyses. Misunderstandings about the value of drug safety activities occur when inappropriate tasks or unrealistic expectations are assigned to these tools. However, used and interpreted appropriately, all of these methods have made major contributions to drug safety.2-4

According to Loke et al, 83% of reports had not been subjected to further evaluation. However, the first question is whether most clinically relevant suspected adverse drug reactions are initially communicated by case reports, and whether this process is efficient—sensitivity combined with low cost . . . [Full text of this article]

Stefan Russmann, assistant professor of epidemiology

Boston Collaborative Drug Surveillance Program, Boston University, Lexington, MA 02421, USA russmann@bu.edu


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Relevant Article

Case reports of suspected adverse drug reactions—systematic literature survey of follow-up
Yoon Kong Loke, Deirdre Price, Sheena Derry, and Jeffrey K Aronson
BMJ 2006 332: 335-339. [Abstract] [Full Text] [PDF]




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