title: Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports.
abstract: 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.
authors.affiliation: Office 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, USA.
authors.forename: Judith U
authors.initials: JU
authors.lastname: Cope
authors.affiliation: Office 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, USA.
authors.forename: Gregory H
authors.initials: GH
authors.lastname: Reaman
authors.affiliation: U.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, USA.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Tonning