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Editorial

Managing the teratogenic risk of thalidomide and lenalidomide: an industry perspective

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Pages 3-8 | Published online: 02 Dec 2010

Bibliography

  • D'Arcy PF, Griffin JP. Thalidomide revisited. Adverse Drug React Toxicol Rev 1994;13:65-7
  • Mellin G, Katzenstein M. The saga of thalidomide. Neuropathy to embryopathy, with case reports of congenital anomalies. N Engl J Med 1962;267:1184-92
  • Lenz W. Kindliche Missbildungen nach Medilamenteinnahme wahrend der Graviditatt? Dtsch Med Wochenschr 1961;86:2555
  • McBride WG. Thalidomide and congenital abnormalities. Lancet 1961;2:1358
  • Smithells RW. Thalidomide and malformations in Liverpool. Lancet 1962;1:1270-3
  • Franks ME, Macpherson GR, Figg WD. Thalidomide. Lancet 2004;363:1802-11
  • Zeldis JB, Williams BA, Thomas SD, S.T.E.P.S®: a comprehensive program for controlling and monitoring access to thalidomide. Clin Ther 1999;21:319-30
  • Castaneda CP, Zeldis JB, Freeman J, RevAssist®: a comprehensive risk minimization programme for preventing fetal exposure to lenalidomide. Drug Saf 2008;31:743-52
  • Teo SK. Properties of thalidomide and its analogues: implications for anticancer therapy. AAPS J 2005;7:E14-19
  • Miller MT, Stromland K. Teratogen update: thalidomide: a review, with a focus on ocular findings and new potential uses. Teratology 1999;60:306-21
  • Snyder JA, Haymond S, Parvin CA, Diagnostic considerations in the measurement of human chorionic gonadotropin in aging women. Clin Chem 2005;51:1830-5
  • Slone SP, Ahmed Z, Cole LA, Positive pregnancy tests in a nongravid, premenopausal woman due to hCG beta-chain production by multiple myeloma. Am J Clin Pathol 2005;124:108-12
  • Uhl K, Cox E, Rogan R, Thalidomide use in the US. Experience with pregnancy testing in the S.T.E.P.S programme. Drug Saf 2006;29:321-9
  • Volume 9A of the Rules Governing Medicinal Products in the European Union: the Guidelines on Pharmacovigilance for Medicinal Products for Human Use
  • Food and Drug Administration. Title IX, the Food and Drug Administration Amendments Act of 2007
  • Renaud C, Burtis J, Azzarrello D, Bwire R. Patient experience with RevAid, a Canadian distribution program for lenalidomide. Abstract accepted for the10th ISoP Meeting; Accra, Ghana; 2010
  • ICH Guideline. E2E. Pharmacovigilance planning. November 2004
  • Food and Drug Administration. Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications, September 2009

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