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REPLY
Pneumonitis with Antiandrogens
Charles L. Bennett, MD, PhD, and
Oliver Sartor, MD
16 September 2003 | Volume 139 Issue 6 | Page 529
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.
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Author and Article Information
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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.
1. McLeod DG. Tolerability of nonsteroidal antiandrogens in the treatment of advanced prostate cancer Oncologist. 1997;2:18-27. [PMID: 10388026].[Abstract/Free Full Text]
2. Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, Bor DH. Timing of new black box warnings and withdrawals for prescription medications JAMA. 2002;287:2215-20. [PMID: 11980521].[Abstract/Free Full Text]
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Pneumonitis Associated with Nonsteroidal Antiandrogens: Presumptive Evidence of a Class Effect
Charles L. Bennett, Dennis W. Raisch, AND Oliver Sartor
- Annals 2002 137: 625.
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