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Pneumonitis with Antiandrogens
- Charles L. Bennett, MD, PhD; and
- Oliver Sartor, MD
- From Veterans Affairs Chicago Healthcare System/Lakeside Division; Chicago, IL 60611; and Louisiana State University School of Medicine; New Orleans, LA 70112. Disclosure: Dr. Bennett has been a consultant to Cell Pathways, Schering-Plough, Inc., and AstraZeneca and has received grant support from the American Cancer Society related to nonsteroidal antiandrogens. Dr. Sartor has been a consultant for Sanofi-Synthelabo, Inc., Atrix Laboratories, Inc., and GTx, Inc., and has served on the monitoring board of Dendreon Corp.
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IN RESPONSE:
As Ahmad and Graham have noted, because of underreporting, there are limitations to using MedWatch data to infer event rates. Randomized clinical trials, which do not have these limitations, identified a 2% rate of interstitial pneumonitis in patients with prostate cancer who received nilutamide (1). Both MedWatch data and the rate estimation method described by Ahmed and Graham, which includes an adjustment for year of marketing and calendar years, indicate that interstitial pneumonitis is at least 50-fold less common with the more commonly used nonsteroidal antiandrogens, bicalutamide and flutamide. Nonetheless, it is most important that physicians are informed of the potential for interstitial pneumonitis in patients taking any of the 3 drugs. Communication of this information is unfortunately inconsistent in the FDA-approved package inserts. Interstitial pneumonitis was described in a black box warning in the original 1996 package insert for nilutamide. In January 2001, the adverse reactions section of the package insert for bicalutamide was revised to indicate that rare occurrences of intersitial pneumonitis were identified in postmarketing reports. However, interstitial pneumonitis is not listed in the current package insert material for flutamide. Lasser and associates (2) found inconsistencies in package inserts for toxicities associated with other classes of pharmaceutical agents. Our findings, in conjunction with those of Lasser and associates, raise concern that inconsistencies in package insert toxicity statements may have important implications for patient safety.
Charles L. Bennett, MD, PhD
Veterans Affairs Chicago Healthcare System/Lakeside Division; Chicago, IL 60611
Oliver Sartor, MD
Louisiana State University School of Medicine; New Orleans, LA 70112
The Editors welcome submissions for possible publication in the Letters section. Authors of letters should:
•Include no more than 300 words of text, three authors, and five references
•Type with double-spacing
•Send three copies of the letter, an authors' form signed by all authors, and a cover letter describing any conflicts of interest related to the contents of the letter.
Letters commenting on an Annals article will be considered if they are received within 6 weeks of the time the article was published. Only some of the letters received can be published. Published letters are edited and may be shortened; tables and figures are included only selectively. Authors will be notified that the letter has been received. If the letter is selected for publication, the author will be notified about 3 weeks before the publication date. Unpublished letters cannot be returned.
Annals welcomes electronically submitted letters.
- Copyright ©2004 by the American College of Physicians
