S.T.E.P.S.(TM): A comprehensive program for controlling and monitoring access to thalidomide

Clinical Therapeutics

Volumn 21, Issue 2, 1999, Pages 319-330

  Zeldis, Jerome B ^a   Williams, Bruce A ^a   Thomas, Steve D ^a   Elsayed, Marc E ^a  

^a CELGENE CORPORATION   (United States)

Author keywords

Congenital abnormalities; Patient education; Prevention; Teratogenicity; Thalidomide

Indexed keywords

CLOZAPINE; ISOTRETINOIN; THALIDOMIDE;

ACNE; AGRANULOCYTOSIS; CONTRACEPTION; DRUG MARKETING; DRUG SAFETY; DRUG USE; EMBRYOPATHY; ERYTHEMA NODOSUM LEPROSUM; FACIAL NERVE PARALYSIS; FOOD AND DRUG ADMINISTRATION; HUMAN; PATIENT COMPLIANCE; PATIENT COUNSELING; PATIENT MONITORING; PHOCOMELIA; PREGNANCY TEST; PRENATAL DRUG EXPOSURE; PRESCRIPTION; REVIEW; SCHIZOPHRENIA; SPONTANEOUS ABORTION; TERATOGENESIS;

EID: 0032922147     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/S0149-2918(00)88289-2     Document Type: Article

References (17)

1. 1. US Food and Drug Administration. FDA Approves Thalidomide for Hansen's Disease Side Effect, Imposes Unprecedented Restrictions on Distribution. Rockville, Md: National Press Office; July 16, 1998. Talk paper.
2. 2. Thalidomide: Potential Benefits and Risk. Transcript of Open Public Scientific Workshop. Bethesda, Md: National Institutes of Health; 1997.
3. 3. Mellin GW, Katzenstein M. The saga of thalidomide. Neuropathy to embryopathy, with case reports of congenital abnormalities. NEJM. 1962;267:1184-1193.
4. 4. Gardner-Medwin JM. Thalidomide in autoimmune conditions. Exp Opin Invest Drugs. 1996;5:829-841.
5. 5. Sheskin J. Thalidomide in the treatment of lepra reactions. Clin Pharmacol Ther. 1965;6:303-306.
6. 6. Sheskin J, Convit J. Results of a doubleblind study on the influence of thalidomide on the lepra reaction. Int J Lepr. 1969;37:135-146.
7. 7. lyer CGS, Languillon J, Ramanuja K, et al. WHO co-ordinated short-term doubleblind trial with thalidomide in the treatment of acute lepra reactions in male lepromatous patients. Bull WHO. 1971;45:719-732.
8. 8. Calabrese L, Resztak K. Thalidomide revisited: Pharmacology and clinical applications. Exp Opin Invest Drugs. 1998;7:2043-2060.
9. 9. Mellin G, Katzenstein M. The saga of thalidomide (concluded). NEJM. 1962;267:1238-1244.
10. 10. Lenz VW, Knapp K. Die Thalidomid-Embryopathie. Dtsch Med Wochenschr. 1962;87:1232-1242.
11. 11. Gunzler V. Thalidomide in human immunodeficiency virus (HIV) patients. A review of safety considerations. Drug Saf. 1992;7:116-134.
12. 12. Stem RS. When a uniquely effective drug is teratogenic. The case of isotretinoin. NEJM. 1989;320:1007-1009.
13. 13. Mitchell AA, Van Bennekom CM, Louik C. A pregnancy-prevention program in women of childbearing age receiving isotretinoin. NEJM. 1995;333:101-106.
14. 14. Kane JM, Honigfeld G, Singer J, and the Clozaril Study Group. Clozapine for the treatment-resistant schizophrenic: Results of a US multicenter trial. Psychopharmacalogy. 1989;99:S60-S63.
15. 15. Kane JM, Honigfeld G, Singer J, and the Clozaril Study Group. Clozapine for the treatment-resistant schizophrenic: A double-blind comparison with chlorprornazine. Arch Gen Psychiatry, 1988;45:789-796.
16. 16. Reducing clorapine-related morbidity and mortality: 5 Years of experience with the Clozaril National Registry. J Clin Psychiatry. 1998;59(Suppl 3):3-7.
17. 17. Honigfeld G. Effects of the Clozapine National Registry System on incidence of deaths related to agranulocytosis, Psychiatr Serv. 1996;47:52-56.