Pneumonitis with Antiandrogens
Authors: Syed Rizwanuddin Ahmad, David J. Graham
Journal: Annals of Internal Medicine (2003)

Letters16 September 2003Pneumonitis with AntiandrogensSyed Rizwanuddin Ahmad, MD, MPH and David J. Graham, MD, MPHSyed Rizwanuddin Ahmad, MD, MPHFrom U.S. Food and Drug Administration; Rockville, MD 20857.Search for more papers by this author and David J. Graham, MD, MPHFrom U.S. Food and Drug Administration; Rockville, MD 20857.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-139-6-200309160-00023 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail 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 ...References1. Bennett CL, Raisch DW, Sartor O. Pneumonitis associated with nonsteroidal antiandrogens: presumptive evidence of a class effect [Letter]. Ann Intern Med. 2002;137:625. [PMID: 12353966] LinkGoogle Scholar2. Graham DJ, Ahmad SR, Piazza Hepp TD. Spontaneous reportingUSA.. In: Mann R, Andrews E, eds. Pharmacovigilance. Chichester, England: J Wiley; 2002:219-28. Google Scholar3. Ahmad SR, Graham DJ, Toyer DP, Wassel R, Mann M. Comparison of pulmonary toxicity risks with antiandrogens [Abstract]. Pharmacoepidemiology and Drug Safety. 2000;9:S121. Google Scholar4. Coultas DB, Zumwalt RE, Black WC, Sobonya RE. The epidemiology of interstitial lung diseases. Am J Respir Crit Care Med. 1994;150:967-72. [PMID: 7921471] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From U.S. Food and Drug Administration; Rockville, MD 20857.Disclaimer: The views in this letter are those of the authors and not necessarily those of the U.S. Food and Drug Administration. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoPneumonitis Associated with Nonsteroidal Antiandrogens: Presumptive Evidence of a Class Effect Charles L. Bennett , Dennis W. Raisch , and Oliver Sartor Pneumonitis with Antiandrogens Charles L. Bennett and Oliver Sartor Metrics Cited BySpontaneous Reporting and Pharmacovigilance Practice: USAPneumonitis with Antiandrogens Severe Hypersensitivity Pneumonitis with Anagrelide Adverse Reactions to a New Food Ingredient Psychiatric Adverse Events with Levetiracetam Levofloxacin-Induced Hemolytic Anemia Levofloxacin and Achilles Tendon Rupture 16 September 2003Volume 139, Issue 6Page: 528-529KeywordsAdverse eventsFood and Drug AdministrationHealth careInterstitial lung diseasesPharmacoepidemiologyPneumonitisPulmonary fibrosisRelative riskResearch designToxicity ePublished: 16 September 2003 Issue Published: 16 September 2003 CopyrightCopyright © 2003 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...