Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports

Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports

Background. Ewing sarcoma family of tumors (ESFT) are rare but deadly cancers of unknown etiology. Few risk factors have been identified. This study was undertaken to ascertain any possible association between exposure to therapeutic drugs and ESFT. Methods. This is a retrospective, descriptive stud...

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Main Authors: Judith U. Cope, Gregory H. Reaman, Joseph M. Tonning
Format: Article
Language:English
Published: Hindawi Limited 2015-01-01
Series:Sarcoma
Online Access:http://dx.doi.org/10.1155/2015/948159
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spelling doaj-7ccaff993e7e4d32b27e6e7a245e7f962020-11-25T00:46:38ZengHindawi LimitedSarcoma1357-714X1369-16432015-01-01201510.1155/2015/948159948159Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event ReportsJudith U. Cope0Gregory H. Reaman1Joseph M. Tonning2Office of Pediatric Therapeutics, Office of Special Medical Programs, Office of the Commissioner/Food and Drug Administration, Building 32, Room 5156, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USAOffice of Hematology and Oncology Products, OND, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak Bldg. 22, Room 2202, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USAU.S. Public Health Service Commissioned Corps, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak Bldg. 22, Room 3410, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USABackground. Ewing sarcoma family of tumors (ESFT) are rare but deadly cancers of unknown etiology. Few risk factors have been identified. This study was undertaken to ascertain any possible association between exposure to therapeutic drugs and ESFT. Methods. This is a retrospective, descriptive study. A query of the FDA Adverse Event Reporting System (FAERS) was conducted for all reports of ESFT, January 1, 1998, through December 31, 2013. Report narratives were individually reviewed for patient characteristics, underlying conditions and drug exposures. Results. Over 16 years, 134 ESFT reports were identified, including 25 cases of ESFT following therapeutic drugs and biologics including immunosuppressive agents and hormones. Many cases were confounded by concomitant medications and other therapies. Conclusions. This study provides a closer look at medication use and underlying disorders in patients who later developed ESFT. While this study was not designed to demonstrate any clear causative association between ESFT and prior use of a single product or drug class, many drugs were used to treat immune-related disease and growth or hormonal disturbances. Further studies may be warranted to better understand possible immune or neuroendocrine abnormalities or exposure to specific classes of drugs that may predispose to the later development of ESFT.http://dx.doi.org/10.1155/2015/948159
collection DOAJ
language English
format Article
sources DOAJ
author Judith U. Cope
Gregory H. Reaman
Joseph M. Tonning
spellingShingle Judith U. Cope
Gregory H. Reaman
Joseph M. Tonning
Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports
Sarcoma
author_facet Judith U. Cope
Gregory H. Reaman
Joseph M. Tonning
author_sort Judith U. Cope
title Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports
title_short Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports
title_full Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports
title_fullStr Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports
title_full_unstemmed Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports
title_sort medication exposures and subsequent development of ewing sarcoma: a review of fda adverse event reports
publisher Hindawi Limited
series Sarcoma
issn 1357-714X
1369-1643
publishDate 2015-01-01
description Background. Ewing sarcoma family of tumors (ESFT) are rare but deadly cancers of unknown etiology. Few risk factors have been identified. This study was undertaken to ascertain any possible association between exposure to therapeutic drugs and ESFT. Methods. This is a retrospective, descriptive study. A query of the FDA Adverse Event Reporting System (FAERS) was conducted for all reports of ESFT, January 1, 1998, through December 31, 2013. Report narratives were individually reviewed for patient characteristics, underlying conditions and drug exposures. Results. Over 16 years, 134 ESFT reports were identified, including 25 cases of ESFT following therapeutic drugs and biologics including immunosuppressive agents and hormones. Many cases were confounded by concomitant medications and other therapies. Conclusions. This study provides a closer look at medication use and underlying disorders in patients who later developed ESFT. While this study was not designed to demonstrate any clear causative association between ESFT and prior use of a single product or drug class, many drugs were used to treat immune-related disease and growth or hormonal disturbances. Further studies may be warranted to better understand possible immune or neuroendocrine abnormalities or exposure to specific classes of drugs that may predispose to the later development of ESFT.
url http://dx.doi.org/10.1155/2015/948159
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AT josephmtonning medicationexposuresandsubsequentdevelopmentofewingsarcomaareviewoffdaadverseeventreports
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