Pharmacovigilance analysis of serious adverse events reported for biologic response modifiers used as prophylaxis against transplant rejection: A real-world postmarketing experience from the us fda adverse event reporting system (faers)

International Journal of Organ Transplantation Medicine

Volumn 4, Issue 2, 2013, Pages 62-71

  Ali, A K ^a  

^a UNIVERSITY OF FLORIDA HEALTH   (United States)

Author keywords

Biologic response modifiers; Faers; Immunosuppressive medications; Pharmacovigilance; Serious adverse events

Indexed keywords

AZATHIOPRINE; BIOLOGICAL RESPONSE MODIFIER; CYCLOPHOSPHAMIDE; CYCLOSPORIN A; DACLIZUMAB; EVEROLIMUS; MYCOPHENOLIC ACID; RAPAMYCIN; TACROLIMUS; THYMOCYTE ANTIBODY;

ABDOMINAL PAIN; ADOLESCENT; ADULT; AGED; ALTERNARIOSIS; ARTICLE; COMA; CONVULSION; CREATININE BLOOD LEVEL; CYTOMEGALOVIRUS INFECTION; DEHYDRATION; DERMATOMYCOSIS; DIARRHEA; DRUG EXPOSURE; DRUG HYPERSENSITIVITY; DRUG RESPONSE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TREATMENT FAILURE; FATALITY; FEMALE; FEVER; GASTROINTESTINAL HEMORRHAGE; GRAFT RECIPIENT; GRAFT REJECTION; GRAFT VERSUS HOST REACTION; HEALING IMPAIRMENT; HEMATOCRIT; HERPES ZOSTER; HUMAN; HYPOTENSION; IMMUNOSUPPRESSIVE TREATMENT; INFUSION RELATED REACTION; KIDNEY GRAFT REJECTION; KIDNEY TUBULE NECROSIS; LENGTH OF STAY; LEUKOCYTE COUNT; LUNG EDEMA; LYMPHOPROLIFERATIVE DISEASE; MALE; NAUSEA; NEUROTOXICITY; ORGAN TRANSPLANTATION; PROPHYLAXIS; PROTEINURIA; PYELONEPHRITIS; RISK BENEFIT ANALYSIS; SERUM SICKNESS; SIDE EFFECT; THROMBOCYTOPENIA; THROMBOTIC THROMBOCYTOPENIC PURPURA; THYROID CANCER; TREATMENT OUTCOME; TREMOR; UNSPECIFIED SIDE EFFECT; URINARY TRACT INFECTION;

EID: 84876805409     PISSN: 20086490     EISSN: 20086482     Source Type: Journal    
DOI: None     Document Type: Article

References (18)

1. Miller BW. Solid Organ Transplant Medicine In: Green GB, Harris IS, Lin GA, Moylan KC, eds.31st ed. St. Louis, MO: Lippincott Williams & Wilkins, The Washington Manual of Medical Therapeutics. 2004
2. Organ Procurement and Transplantation Network (OPTN), United Network for Organ Sharing (UNOS). Data as of January 30 2013. Rockville, MD: Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation, 2013. Available at:(Accessed January 30). http://optn.transplant. hrsa.gov/ 2013
3. US Government Information on Organ and Tissue Donation and Transplantation. The Need is Real: Data. Rockville,MD: Department of Health and Human Services, Health Resources and Services Administration; 2012.Available at:(Accessed January 30). www.organdonor. gov/about/data.html 2013
4. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2011 Annual Data Report. Rockville,MD: Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation, 2012. Available from:(Accessed January 30, http:// srtr.transplant.hrsa.gov/annual_reports/2011/ pdf/2011_SRTR_ADR.pdf 2013.
5. National Guideline Clearinghouse (NGC). Guideline Summary: Guidelines on Renal Transplantation: Immunosuppression after Kidney Transplantation. Rockville, MD Agency for Healthcare Research and Quality (AHRQ); 2010. Available at: (Accessed January 30, www.guideline.gov/content.aspx?id=14833 2013
6. Ali AK. Pharmacovigilance analysis of adverse event reports for Aliskiren Hemifumarate, a firstin-class direct renin inhibitor. Therap Clin Risk Manag 2011;7:337-44.
7. US Food and Drug Administration (FDA). FDA Adverse Event Reporting System (FAERS). Silver Spring: MD: US Department of Health and Human Services, Food and Drug Administration; 2012. Available from: www.fda.gov/Drugs/Guidance-ComplianceRegulatoryInformation/Surveillance/ AdverseDrugEffects/default.htm (Accessed January 30, 2013).
8. US Food and Drug Administration (FDA). Code of Federal Regulations Title 21. Silver Spring: MD: US Department of Health and Human Services, Food and Drug Administration; 2012. Available from: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ cfrsearch.cfm?fr=312.32 (Accessed January 30, 2013).
9. DuMouchel W. Bayesian data Mining in large Frequency Tables, with an Application to the FDA Spontaneous Reporting System (with Discussion). Am Statistician 1999;53:177-90.
10. Bate A, Edwards IR. Data Mining Techniques in Pharmacovigilance. In: Hartzema AG, Tilson HH, Chan KA, editors. Pharmacoepidemiology and Therapeutic Risk Management. 1st ed. Cincinnati, OH: Harvey Whitney Books Co, 2008.
11. Food and Drug Administration (FDA). Drug Safety Communication. Safety Review Update on Reports of Hepatosplenic T-cell Lymphoma in Adolescents and Young Adults Receiving Tumor Necrosis Factor (TNF) Blockers, Azathioprine and/or Mercaptopurine. FDA; April 14, 2011. Available at www.fda.gov/Drugs/DrugSafety/ucm250913.htm (Accessed February 3, 2013).
12. Fishman JA. Overview: cytomegalovirus and the herpesviruses in transplantation. Am J Transplant 2013;13(Suppl 3):1-8.
13. Piselli P, Busnach G, Fratino L, et al. De novo malignancies after organ transplantation: focus on viral infections. Curr Mol Med 2013 [Epub ahead of print].
14. Gutierrez-Dalmau A, Campistol JM. Immunosuppressive therapy and malignancy in organ transplant recipients: a systematic review. Drugs 2007;67:1167-98.
15. Hengster P, Pescovitz MD, Hyatt D, Margreiter R. Cytomegalovirus infections after treatment with daclizumab, an anti IL-2 receptor antibody, for prevention of renal allograft rejection. Roche Study Group. Transplantation 1999;68:310-3.
16. Bechstein WO. Neurotoxicity of calcineurin inhibitors: impact and clinical management. Transplant Int 2000;13:313-26.
17. Bielory L, Gascon P, Lawley TJ, et al. Serum sickness and haematopoietic recovery with antithymocyte globulin in bone marrow failure patients. Br J Haematol 1986;63:729-36.
18. Mahmud n, Klipa D, Ahsan N. Antibody immunosuppressive therapy in solid-organ transplant: part I. MABS 2010;2:148-156.