What is the best approach to reducing birth defects associated with isotretinoin?

PLoS Medicine

Volumn 3, Issue 11, 2006, Pages 1978-1983

  Abroms, Lorien ^a   Maibach, Edward ^a   Lyon Daniel, Katherine ^b   Feldman, Steven R ^c  

^a GEORGE WASHINGTON UNIVERSITY   (United States)

^b NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL DISABILITIES   (United States)

^c WAKE FOREST SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ISOTRETINOIN;

ACNE; BIRTH CONTROL; BIRTH DEFECT; FETUS MALFORMATION; HEALTH PROGRAM; HUMAN; INTERMETHOD COMPARISON; INTERNET; MEDICAL INFORMATION; NONHUMAN; PREGNANT WOMAN; REVIEW; RISK MANAGEMENT; RISK REDUCTION; TERATOGENESIS; ACNE VULGARIS; CONGENITAL MALFORMATION; DRUG CONTRAINDICATION; FEMALE; METHODOLOGY; PREGNANCY;

ABNORMALITIES, DRUG-INDUCED; ACNE VULGARIS; FEMALE; HUMANS; ISOTRETINOIN; PREGNANCY; RISK MANAGEMENT;

EID: 33845346759     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.0030483     Document Type: Review

References (37)

1. Lehmann HP, Robinson KA, Andrews JS, Holloway V, Goodman SN (2002) Acne therapy: A methodologic review. J Am Acad Dermatol 47: 231-240.
2. Jewett S, Ryan T (1985) Skin disease and handicap: An analysis of the impact of skin conditions. Soc Sci Med. 20: 425-429.
3. Cunliffe WJ (1986) Acne and unemployment. Br J Dermatol 115: 386.
4. Cotterill JA, Cunliffe WJ (1997) Suicide in dermatological patients. Br J Dermatol 137: 246-250.
5. Strauss JS, Rapini RP, Shalita AR, Konecky E, Pochi PE, et al. (1984) Isotretinoin therapy for acne: Results of a multicenter dose-response study. J Am Acad Dermatol 10: 490-496.
6. Lammer EJ, Chen DT, Hoar RM, Agnish ND, Benke PJ, et al. (1985) Retinoic acid embryopathy. N Engl J Med.; 313(14):837-841.
7. Mitchell AA, Van Bennekom CM, Louik C (1995) A pregnancy-prevention program in women of childbearing age receiving isotretinoin. N Engl J Med 333: 101-106.
8. Lindstrom J (2004) Isotretinoin: Background and regulatory history. FDA Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Meeting. February 26-27, 2004. Available: http://www.fda.gov/ohrms/dockets/ac/04/slides/4017s1.htm. Accessed 13 October 2006.
9. Wysowski DK, Pitts M, Beitz J (2001) An analysis of reports of depression and suicide in patients treated with isotretinoin. J Am Acad Dermatol 45: 515-519.
10. Stern RS (2000) Medication and medical service utilization for acne 1995-1998. J Am Acad Dermatol 43: 1042-1048.
11. Chen K, White TJ, Juzba M, Chang E (2002) Oral isotretinoin: An analysis of its utilization in a managed care organization. J Manag Care Pharm 8: 272-277.
12. Wysowski DK, Swann J, Vega A (2002) Use of isotretinoin (Accutane) in the United States: Rapid increase from 1992 through 2000. J Am Acad Dermatol 46: 505-509.
13. Food and Drug Administration (2006) iPLEDGE update. Available: http://www.fda.gov/cder/drug/infopage/accutane/iPLEDGEupdate200603.htm. Accessed 18 October 2006.
14. McGuire WJ (1984) Public communication as a strategy for inducing health-promoting behavioral change. Prev Med 13: 299-319.
15. Synder LB, Hamilton MA, Mithchell EW, Kiwanuka-Tondo J, Fleming-Milici F, et al. (2004) A meta-analysis of the effect of mediated health communication campaigns on behavior change in the United States. J Health Commun 9 (Suppl 1): 71-96.
16. Bandura A (1986) Social foundations of thought and action: A social cognitive theory. Englewood Cliffs (NJ): Prentice-Hall. 544 p.
17. Glanz K, Rimer BK, Lewis FM, editors (2002) Health behavior and health education: Theory, research and practice. 3rd edition. San Francisco: Jossey-Bass. 624 p.
18. Food and Drug Administration (1983) Dermatologic Drugs Advisory Committee Transcript: October 21, 1983. Available: http://www.fda.gov/ohrms/dockets/ac/ accutane.htm. Accessed 18 October 2006.
19. Food and Drug Administration (1988) Dermatologic Drugs Advisory Committee Transcript: April 26, 1988. Available: http://www.fda.gov/ohrms/dockets/ac/ accutane.htm. Accessed 18 October 2006.
20. Perlman SE, Leach EE, Dominguez L, Ruszkowski AM, Rudy SJ (2001) "Be smart, be safe, be sure". The revised Pregnancy Prevention Program for women on isotretinoin. J Reprod Med 46 (Suppl 2): 179-185.
21. Honein MA, Paulozzi LJ, Erickson JD (2001) Continued occurrence of Accutane-exposed pregnancies. Teratology 64: 142-147.
22. Brinker A, Kornegay C, Nourjah P (2005) Trends in adherence to a revised risk management program designed to decrease or eliminate isotretinoin-exposed pregnancies. Arch Dermatol 141: 563-569.
23. Shiff SA (2004) Overview of SMART Program. FDA Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Meeting. February 26-27, 2004. Available: http://www.fda.gov/ohrms/dockets/ac/ 04/slides/4017s1.htm. Accessed 18 October 2006.
24. Darves B (2006 March 9) Dermatologists frustrated with problematic iPledge program. Medscape Medical News. Available: http://www.medscape.com/ viewarticle/525664. Accessed 18 October 2006.
25. Harris G (2006 February 11) System said to fail to steer women from acne drug. The New York Times. Available: http://www.nytimes.com/2006/02/11/national/ 11inhibit.html. Accessed 18 October 2006.
26. Huber MH (2004) Review of Data from SMART Program. FDA Joint Dermatologic and Ophthalmic Drugs & Drug Safety and Risk Management Advisory Committee Meeting. February 26-27, 2004. Available: http://www.fda.gov/ohrms/dockets/ac/ 04/slides/4017s1.htm. Accessed 18 October 2006.
27. Brown SS, Eisenberg L, editors (1995) The best intentions: Unintended pregnancy and the well-being of children and families. Washington (D. C.): National Academy Press. 392 p.
28. Honein MA, Moore CA, Erickson JD (2004) Can we ensure the safe use of known human teratogens? Drug Saf 27: 1069-1080.
29. Andreasen AR (1995) Marketing social change: Changing behavior to promote health, social development, and the environment. San Francisco: Jossey-Bass. 368 p.
30. Doak CC, Doak LG, Root JH (1996) Teaching patients with low literacy skills. Philadelphia: Lippincott.
31. Chen SC, Bayoumi AM, Soon SL, Aftergut K, Cruz P, et al. (2004) A catalog of dermatology utilities: A measure of the burden of skin diseases. J Investig Dermatol Symp Proc 9: 160-168.
32. Rohrback JM, Fleischer AB Jr, Krowchuk DP, Feldman SR (2004) Depression is not common in isotretinoin-treated acne patients. J Dermatolog Treat 15: 252.
33. Jick SS, Kremers HM, Vasilakis-Scaramozza C (2000) Isotretinoin use and risk of depression, psychotic symptoms, suicide, and attempted suicide. Arch Dermatol 136: 1231-1236.
34. Fleischer AB Jr, Simpson JK, McMichael A, Feldman SR (2003) Are there racial and sex differences in the use of oral isotretinoin for acne management in the United States? J Am Acad Dermatol 49: 662-666.
35. Cheetham TC, Wagner RA, Chiu G, Day JM, Yoshinaga MA, et al. (2006) A risk management program aimed at preventing fetal exposure to isotretinoin: Retrospective cohort study. J Am Acad Dermatol 55: 442-448.
36. Thevarajah S, Balkrishnan R, Camacho FT, Feldman SR, Fleischer AB Jr (2005) Trends in prescription of acne medication in the US: Shift from antibiotic to non-antibiotic treatment. J Dermatolog Treat 16: 224-228.
37. Jordan AY, Parks L, Chen SC, Higgins K, Fleischer AB, et al. (2005) Does the teratogenicity of isotretinoin outweigh its benefi ts? J Dermatolog Treat 16: 190-192.