Finding, evaluating, and managing drug-related risks: Approaches taken by the US food and drug administration (FDA)

Dermatologic Therapy

Volumn 22, Issue 3, 2009, Pages 204-215

  Weaver, Joyce ^a   Grenade, Lois La ^a   Kwon, Hyon ^b   Avigan, Mark ^b  

^a Divisions of Risk Management ^*

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Pharmaceutical risk; Postmarketing product surveillance

Indexed keywords

ABACAVIR; ADALIMUMAB; ANTIBIOTIC AGENT; BECAPLERMIN; BIOLOGICAL MARKER; CALCINEURIN INHIBITOR; CARBAMAZEPINE; EFALIZUMAB; ETANERCEPT; INFLIXIMAB; ISOTRETINOIN; METHOXSALEN; NATALIZUMAB; PHENYTOIN; PIMECROLIMUS; RITUXIMAB; TACROLIMUS; TUMOR NECROSIS FACTOR ALPHA INHIBITOR;

ACNE; ANKYLOSING SPONDYLITIS; ATOPIC DERMATITIS; CROHN DISEASE; DISEASE REGISTRY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG MONITORING; DRUG PROTEIN BINDING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GENETIC RISK; GRAFT REJECTION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION; INFLAMMATORY DISEASE; LUNG TUBERCULOSIS; MEDICAL RECORD REVIEW; MYCOSIS; NECROTIZING FASCIITIS; NEUTROPENIA; PACKAGING; PHARMACOGENOMICS; PNEUMONIA; POSTMARKETING SURVEILLANCE; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; PSORIASIS; PSORIATIC ARTHRITIS; PUVA; REPEATED DRUG DOSE; REVIEW; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; RISK FACTOR; RISK MANAGEMENT; SEPSIS; STEVENS JOHNSON SYNDROME; TOXIC EPIDERMAL NECROLYSIS; ULCER; ULCERATIVE COLITIS; VIRUS MENINGITIS;

DERMATOLOGIC AGENTS; DRUG APPROVAL; HUMANS; RISK FACTORS; RISK MANAGEMENT; SKIN DISEASES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 65549169154     PISSN: 13960296     EISSN: 15298019     Source Type: Journal    
DOI: 10.1111/j.1529-8019.2009.01233.x     Document Type: Review

References (48)

1. Guidance for Industry. Premarketing risk assessment. http://www.fda.gov/ cder/guidance/6357fnl.htm. Accessed October 16, 2008.
2. Reynolds RF, Glasser DB, Dieck GS. A View from Industry. In : Strom BL, ed. Pharmacoepidemiology, 4th ed. Hoboken, NJ : John Wiley & Sons Ltd., 2005 : 79.
3. Jonas S, Rayes N, Neumann U, et al. De novo malignancies after liver transplantation using tacrolimus-based protocols or cyclosporine-based quadruple immunosuppression with an interleukin-2 receptor antibody or antithymocyte globulin. Cancer 1997 : 80 (6 1141 1150. (Pubitemid 27427615)
4. US Food and Drug Administration. Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee Meeting #54, November 16, 2000 [transcript]. http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3659t1c. pdf. Accessed October 21, 2008.
5. Protopic [package insert]. Deerfield, IL : Astellas Pharma US, Inc., 2006.
6. Elidel [package insert]. East Hanover, NJ : Novartis, 2007.
7. Praghakaran K, Wise B, Chen A, Schwarz K, Colombani P. Rational management of posttransplant lymphoproliferative disorder in pediatric recipients. J Pediatr Surg 1999 : 34 (1 112 115 discussion 115-116. (Pubitemid 29047263)
8. US Food and Drug Administration. Elidel approval letter 2001. http://www.fda.gov/cder/foi/nda/2001/21-302-ELIDEL-Approv.pdf. Accessed October 21, 2008.
9. US Food and Drug Administration. Food and Drug Administration Dermatologic And Ophthalmic Drugs Advisory Committee Meeting #54, November 16, 2000 [transcript]. http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3659t1c. pdf. Accessed October 21, 2008.
10. US Food and Drug Administration. Protopic approval letter 2000. http://www.fda.gov/cder/foi/appletter/2000/50777ltr.pdf. Accessed October 21, 2008.
11. Genentech. Important drug warning regarding RAPTIVA® [efalizumab]. http://www.fda.gov/medwatch/SAFETY/2005/raptiva-deardoc-071205.pdf. Accessed October 21, 2008.
12. Raptiva [package insert]. San Francisco, CA : Genentech, Inc., October, 2008.
13. Genentech. Important safety information. http://www.gene.com/gene/ products/information/pdf/raptiva-dhcp.pdf. Accessed October 23, 2008.
14. Genentech. Important drug warning regarding Raptiva® [efalizumab]. http://www.gene.com/gene/products/information/pdf/raptiva-dhcp-1008.pdf. Accessed October 23, 2008.
15. Keane J, Gershon S, Wise RP, et al. Tuberculosis associated with infliximab, a tumor necrosis factor a-neutralizing agent. NEJM 2001 : 345 (15 1098 1104.
16. Mackey AC, Green L, Liang LC, Dinndorf P, Avigan M. Hepatosplenic T cell lymphoma associated with infliximab use in young patients treated for inflammatory bowel disease. J Pediatr Gastroenterol Nutr 2007 : 44 (2 265 267. (Pubitemid 46175082)
17. US Food and Drug Administration. Early communication about an ongoing safety review of tumor necrosis factor (TNF) blockers. http://www.fda.gov/cder/ drug/early-comm/TNF-blockers.htm. Accessed October 23, 2008.
18. US Food and Drug Administration. Communication about an ongoing safety review of Regranex (becaplermin). http://www.fda.gov/cder/drug/early-comm/ becaplermin.htm. Accessed October 21, 2008.
19. US Food and Drug Administration. Update of safety review: follow-up to the March 27, 2008, communication about the ongoing safety review of Regranex (becaplermin). http://www.fda.gov/cder/drug/early-comm/becaplermin-update- 200806.htm. Accessed October 21, 2008.
20. Rossouw JE, Anderson GL, Prentice RL, et al. Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA 2002 : 288 (3 321 333.
21. Strom BL, Faich GA, Reynolds RF, et al. The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC): design and baseline subject characteristics. J Clin Psychiatr 2008 : 69 (1 114 121.
22. Nelson HS, Weiss ST, Bleecker ER, et al. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest 2006 : 129 (1 15 26. Erratum in Chest 2006: 129 (5): 1393. (Pubitemid 43265239)
23. Stern RS, Thibodeau LA, Kleinerman RA, Parrish JA, Fitzpatrick TB. Risk of cutaneous carcinoma in patients treated with oral methoxsalen photochemotherapy for psoriasis. N Engl J Med 1979 : 300 (15 809 813. (Pubitemid 9165020)
24. Stern RS, Laird N, Melski J, et al. Cutaneous squamous-cell carcinoma in patients treated with PUVA. N Engl J Med 1984 : 310 (18 1156 1161. (Pubitemid 14135391)
25. Stern RS; PUVA Follow up Study. The risk of melanoma in association with long-term exposure to PUVA. J Am Acad Dermatol 2001 : 44 (5 755 761. (Pubitemid 32391161)
26. Stern RS. Squamous-cell cancer of the skin in patients given PUVA and ciclosporin: nested cohort crossover study. Lancet 2001 : 358 (9287 1042 1045. (Pubitemid 32925124)
27. Nijsten TE, Stern RS. The increased risk of skin cancer is persistent after discontinuation of psoralen + ultraviolet A: a cohort study. J Invest Dermatol 2003 : 121 (2 252 258. (Pubitemid 36969897)
28. Food and Drug Administration Amendments Act of 2007, HR 358021 USC 351, et seq (2007).
29. Tikosyn [package insert]. New York, NY : Pfizer, 2004.
30. Identification of drug and biological products deemed to have risk evaluation and mitigation strategies for purposes of the Food and Drug Administration Amendments Act of 2007. Federal Register 73 : 16313 16314 (March 27, 2008).
31. US FDA. Guidance for Industry. Development and use of risk minimization action plans. http://www.fda.gov/cder/guidance/6358fnl.htm. Accessed October 16, 2008.
32. US Food and Drug Administration. Pregnancy prevention program: a risk management program to reduce pregnancies during Accutane treatment, Roche summaryof program. http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3639b1c-06. pdf. Accessed October 16, 2008.
33. US Food and Drug Administration. Historical information on isotretinoin (marketed as Accutane). http://www.fda.gov/cder/drug/infopage/accutane/accutane- historical.htm. Accessed October 16, 2008.
34. Mendelsohn AB, Governale L, Trontell A, Seligman P. Changes in isotretinoin prescribing before and after implementation of the System to Manage Accutane Related Teratogenicity (SMART) risk management program. Pharmacoepidemiol Drug Saf 2005 : 14 (9 615 618. (Pubitemid 41358697)
35. Brinker A, Kornegay C, Nourjah P. Trends in adherence to a revised risk management program designed to decrease or eliminate isotretinoin-exposed pregnancies. Arch Dermatol 2005 : 141 : 563 569.
36. US Food and Drug Administration. US FDA iPLEDGE update, March 23, 2006. http://www.fda.gov/cder/drug/infopage/accutane/iPLEDGEupdate200603.htm. Accessed October 16, 2008.
37. Evans WE, McLeod HL. Pharmacogenomics - drug disposition, drug targets, and side effects. N Engl J Med 2003 : 348 : 538 549. (Pubitemid 36159890)
38. Pirmohamed M, Park BK. Genetic susceptibility to adverse drug reactions. Trends Pharmacol Sc 2001 : 22 : 298 305. (Pubitemid 32523913)
39. Frueh FW, Amur S, Mummaneni P, et al. Pharmacogenomic biomarker information in drug labels approved by the United States Food and Drug Administration: prevalence of related drug use. Pharmacother 2008 : 28 : 992 998.
40. US Food and Drug Administration. Table of valid genomic biomarkers in the context of approved drug labels. http://www.fda.gov/cder/genomics/genomic- biomarkers-table.htm. Accessed October 21, 2008.
41. Avigan M. Pharmacogenomic biomarkers of susceptibility to adverse drug reactions: just around the corner or pie in the sky? Personalized Medicine 2009 : 6 (1 67 78.
42. Hung SI, Chang WH, Lee SH, et al. Genetic susceptibility to carbamazepine-induced cutaneous adverse drug reactions. Pharmacogenet Genomics 2006 : 16 (4 297 306.
43. US Food and Drug Administration. Information for healthcare professionals: carbamazepine. http://www.fda.gov/cder/drug/InfoSheets/HCP/ carbamazepineHCP.htm. Accessed October 21, 2008.
44. Locharemkul C, Loplumlert J, Limotai C, et al. Carbamazepine and phenytoin induced Stevens-Johnson syndrome is associated with HLA-B*1502 allele in Thai population. Epilepsia 2008 : 49 (12 2087 2091.
45. Ingelman-Sundberg M. Pharmacogenomic biomarkers for prediction of severe adverse drug reactions. N Engl J Med 2008 : 358 (6 637 639.
46. Mallal S, Phillips E, Carosi G, et al. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med 2008 : 358 (6 568 579.
47. Saag M, Balu R, Phillips E, et al. High sensitivity of human leukocyte antigen-B*5701 as a marker for immunologically confirmed abacavir hypersensitivity in white and black patients. Clin Infect Dis 2008 : 46 (7 1111 1118.
48. Best Pharmaceuticals for Children Act of 2002, Public Law No. 107-109, 115 Stat. 1408 (codified as amended in scattered sections of 21 USC and 42 USC).