Syed Rizwanuddin Ahmad, MD, MPH; David J. Graham, MD, MPH
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Ahmad SR, Graham DJ. Pneumonitis with Antiandrogens. Ann Intern Med. 2003;139:528-529. doi: 10.7326/0003-4819-139-6-200309160-00023
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Published: Ann Intern Med. 2003;139(6):528-529.
TO THE EDITOR:
Bennett and colleagues (1) rightly reminded prescribers about the association of pneumonitis with antiandrogens. The authors calculated the incidence of pneumonitis on the basis of the number of cases reported to the U.S. Food and Drug Administration (FDA)'s Adverse Event Reporting System and the number of persons using antiandrogens. However, the calculation of incidence rates from spontaneously reported data is fundamentally flawed because of extensive underreporting; fewer than 10% of serious reactions are reported to the FDA (2). Moreover, reporting can be influenced by several factors, including the length of time a product has been on the market, reporting practices of pharmaceutical companies, physicians' awareness of the event, and publicity effects. For these reasons, reporting rates are not incidence rates and should be interpreted with caution.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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